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PT. ROCHE INDONESIA

Authorized Representative in Indonesia

Gedung AIA Central Lantai 36 Jl. Jend. Sudirman KAV. 48A RT/RW 003/004 Kelurahan Karet Semanggi
1074 Products Represented
85 Manufacturers
Total Products
1074
Manufacturers
85
Product Classes
3
Risk Classes
4
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
155 products
14.4%
Kelas Resiko : B
682 products
63.5%
Kelas Resiko : C
200 products
18.6%
Kelas Resiko : D
37 products
3.4%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (1074)
Complete portfolio registered with BPOM

COBAS PreciControl CMV IgG Avidity Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 11, 2025

COBAS MPXV

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 11, 2025

COBAS CREP2 Creatinine Plus ver.2 COBAS INTEGRA / cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 10, 2025

COAGUCHEK PT Test

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 6, 2025

COBAS S2 Fluid Pack

Manufacturer:

ROCHE DIAGNOSTICS INTERNATIONAL, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2025

ROCHE Cardiac POC Troponin T 2-Level Control

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 4, 2025

COBAS Elecsys CA 15-3 ll Elecsys and cobas e analyzer

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 26, 2025

COBAS u 601 Urine Analyzer and Accessories

Manufacturer:

77 ELECTRONICS INSTRUMENT INDUSTRY LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2025

ISE Reference Electrolyte Roche / Hitachi cobas c

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 23, 2025

COBAS CA 19-9 Calset Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 23, 2025

COBAS Insulin CalSet Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 23, 2025

COBAS NSE Elecsys and Cobas e Analyzer

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 23, 2025

COBAS Elecsys Anti-HAV IgM Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 22, 2025

COBAS Elecsys Anti-TPO Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 20, 2025

COBAS C.f.a.s. Myoglobin Calibrator for automated systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 20, 2025

COBAS u 701 Microscopy Analyzer and Accessories

Manufacturer:

77 ELECTRONICS INSTRUMENT INDUSTRY LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 17, 2025

COBAS Elecsys HBeAg Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 13, 2025

COBAS p 512 Pre Analytical System and Accessories

Manufacturer:

ROCHE DIAGNOSTICS AUTOMATION SOLUTION GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 8, 2025

ELECSYS proBNP II cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 3, 2025

ACCUTREND Plus

Manufacturer:

LRE MEDICAL GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 2, 2025

COBAS Elecsys HCG+ß cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 30, 2024

COBAS Elecsys CA 15-3 II cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 27, 2024

COBAS Elecsys CA 125 II cobas and analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 27, 2024

COBAS LDHI2 (Lactate Dehydrogenase acc. IFCC ver.2

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2024

ACCUTREND Control CH1

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 26, 2024

ELECSYS Troponin T hs cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 24, 2024

COBAS Elecsys PTH

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 24, 2024

COBAS Elecsys Progesterone III cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 23, 2024

MICRAL-TEST Microalbuminurie

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 23, 2024

COBAS DHEA-S Elecsys and Cobas e Analyzer

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 23, 2024

COAGUCHEK aPTT Controls

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 23, 2024

Elecsys FSH cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 23, 2024

COBAS Deproteinizer

Manufacturer:

ROCHE DIAGNOSTICS INTERNATIONAL, LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 23, 2024

ROCHE CARDIAC Myoglobin cobas h 232

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 23, 2024

COBAS Control-Test M

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 23, 2024

ACCUTREND Control TG1

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 19, 2024

COBAS LI (Lithium) cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 19, 2024

COAGUCHEK PT Controls

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 19, 2024

COBAS ISE Diluent Gen.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 17, 2024

Elecsys CA 72-4 cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 17, 2024

COBAS PreciControl Anti-HBe Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 17, 2024

ROCHE CARDIAC Control proBNP cobas h 232

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 17, 2024

COBAS PreciControl HBeAg Elecsys and Cobas e Analy

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 16, 2024

COBAS β -CrossLaps CalSet Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 13, 2024

ELECSYS GAAD

Manufacturer:

ROCHE DIAGNOSTICS INTERNATIONAL LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 13, 2024

COBAS DNA Sample Preparation Kit (DNA SP)

Manufacturer:

ROCHE MOLECULAR SYSTEMS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 13, 2024

COBAS Preciset DAT Plus II

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 13, 2024

COBAS BM-Control-Lactate

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 13, 2024

COBAS PreciControl Anti-HAV IgM Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 12, 2024

cobas Liat Analyzer and Accessories

Manufacturer:

ROCHE DIAGNOSTICS INTERNATIONAL LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 12, 2024

COBAS 4800 BRAF V600 Mutation Test

Manufacturer:

ROCHE MOLECULAR SYSTEMS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 12, 2024

ELECSYS HCG+β

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 6, 2024

COBAS CHED2 Cholinesterase/Dibucaine Gen.2 COBAS INTEGRA / cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 4, 2024

ELECSYS HIV Duo cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 3, 2024

COBAS ISE Internal Standard Gen.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 2, 2024

COBAS Pro ISE Analytical Unit and Accessories

Manufacturer:

HITACHI HIGH-TECHNOLOGIES CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 2, 2024

COBAS Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 2, 2024

PreciControl Anti-SARS-CoV-2 cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 2, 2024

COBAS KRAS Mutation Test

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 2, 2024

ROCHE Elecsys HE4 Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 28, 2024

COBAS x 480 and Accessories

Manufacturer:

HAMILTON BONADUZ AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 28, 2024

COBAS ISE Reference Electrolyte Roche/Hitachi

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 28, 2024

COBAS Cdiff Nucleic acid test for use on the cobas Liat System

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 28, 2024

COBAS Strep A Nucleic acid test for use on the cobas Liat System

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 28, 2024

COBAS Strep A Quality Control Kit for use on the cobas Liat System

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 26, 2024

COBAS DHEA-S Calset Elecsys and Cobas e Analyzer

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 26, 2024

COBAS® Pulse and Accessories

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 22, 2024

ACCU-FINE Pen Needles

Manufacturer:

HTL-STREFA S.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 15, 2024

VENTANA Bluing Reagent

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 9, 2024

COBAS ALTL Alanine Aminotransferase COBAS INTEGRA / cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 6, 2024

COBAS THC2 ONLINE DAT Cannabinoids II cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 6, 2024

COBAS Anti-Tg CalSet Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 6, 2024

COBAS Cleaning Solution

Manufacturer:

ROCHE DIAGNOSTICS INTL, LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 6, 2024

COBAS omni MGP Reagent

Manufacturer:

ROCHE MOLECULAR SYSTEMS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 1, 2024

9180 Electrolyte Analyzer and Accessories

Manufacturer:

ROCHE DIAGNOSTICS INTERNATIONAL, LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 1, 2024

ELECSYS N-MID Osteocalcin Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 1, 2024

COBAS b 221 System and Accessories

Manufacturer:

ROCHE DIAGNOSTICS INTL LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 1, 2024

COBAS PHOS2 cobas c 111 Phosphate ver.2

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 1, 2024

COBAS MPX

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 30, 2024

COBAS LDHI2 cobas c111 Lactate Dehydrogenase acc. to IFCC ver.2

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 28, 2024

COBAS IgE CalSet Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2024

COBAS Diluent NSE Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2024

COBAS PreciControl Cardiac II Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2024

COBAS PTH Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2024

COBAS PreciControl HE4 Elecsys and cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 21, 2024

COBAS HE4 CalSet Elecsys and cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 21, 2024

COBAS Anti-TPO CalSet Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 21, 2024

COBAS Elecsys CA 19-9 Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 18, 2024

COBAS THEO2 ONLINE TDM Theophylline cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 18, 2024

COBAS ALBT2 Tina-quant Albumin Gen.2 Cobas Integra/ cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 16, 2024

COBAS AMY-P cobas c 111 α -Amylase EPS Pancreatic

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 16, 2024

VENTANA HybReady Solution

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 14, 2024

VENTANA HER2 Dual ISH 3-in-1 Xenograft Slides

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 14, 2024

COBAS A1CD2 cobas c 111 Hemolyzing Reagent Gen.2

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 14, 2024

COBAS Elecsys Anti-HBe Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 14, 2024

Control Set β2-Microglobulin Roche systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 11, 2024

COBAS Calibrator β-Microglobulin Roche Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 11, 2024

COBAS TPUC3 Total Protein Urine/CSF Gen.3 COBAS INTEGRA/ cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 11, 2024

Cobas® GLU Linearity Kit

Manufacturer:

BIONOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 9, 2024

ROCHE CARDIAC D-Dimer cobas h 232

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 8, 2024

COBAS IGA-2 Tina-quant IgA Gen.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 8, 2024

IGG-2 Tina-quant IgG Gen.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 7, 2024

COBAS Elecsys Progesterone III Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 7, 2024

COBAS S1 Rinse Solution cobas b 221, Roche OMNI S

Manufacturer:

ROCHE DIAGNOSTICS INTL, LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 7, 2024

PATHWAY HER-2 4 in 1 Control Slides

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 7, 2024

ROCHE CARDIAC CK-MB cobas h 232

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 7, 2024

COBAS ELECSYS Anti-HBs II cobas e 801 analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 4, 2024

COBAS e 402 Analytical Unit and Accessories

Manufacturer:

HITACHI HIGH-TECH CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 2, 2024

COBAS Elecsys Anti-HBS II cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 2, 2024

COBAS ASLOT Tina-quant Antisterptolysin O cobas c

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 1, 2024

ELECSYS HBsAg II cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 1, 2024

COBAS p 612 Pre Analytical System and Accessories

Manufacturer:

ROCHE DIAGNOSTICS AUTOMATION SOLUTION GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 1, 2024

COBAS Elecsys HBsAg II quant II cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 27, 2024

COBAS CRP Control cobas b 101

Manufacturer:

CLINIQA CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 23, 2024

ACCU-CHEK Guide Wireless Blood Glucose Meter Only

Manufacturer:

SANMINA SCI INDIA PVT LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 17, 2024

ACCU-CHEK Guide Set Wireless Blood Glucose Meter and Lancing Device

Manufacturer:

SANMINA SCI INDIA PVT LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 17, 2024

COMBITROL Plus B Level 3

Manufacturer:

BIONOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 11, 2024

ROCHE/HITACHI Cell Wash Solution I / NAOH-D

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 11, 2024

VALP2 ONLINE TDM Valproic Acid cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 11, 2024

COBAS SARS-CoV-2 Quality Control Kit for use on the cobas Liat System

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 11, 2024

COBAS HCYS Homocysteine Enzymatic Assay COBAS INTEGRA/ Cobas c Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 10, 2024

VENTANA PD-L1 (SP263) Assay

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 9, 2024

Elecsys free βhCG cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 9, 2024

COBAS SARS-CoV-2 Nucleic acid test for use on the cobas Liat System

Manufacturer:

ROCHE MOLECULAR SYSTEMS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 8, 2024

COBAS Hb-Calibrator cobas b 221, Roche OMNI S

Manufacturer:

ROCHE DIAGNOSTICS INTERNATIONAL, LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 4, 2024

COBAS LPA2 Tina-quant Lipoprotein (a) Gen.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 4, 2024

PreciControl AMH Plus Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 3, 2024

COBAS IGM-2 Tina-quant IgM Gen.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 3, 2024

COBAS MYO2 (Tina-quant Myoglobin Gen.2) Cobas Integra / cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 30, 2024

COBAS PIK3CA Mutation Test (PIK3CA)

Manufacturer:

ROCHE MOLECULAR SYSTEMS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 30, 2024

COBAS LPA2 Tina-quant Lipoprotein (a) Gen.2 Cobas c Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 28, 2024

COBAS SI2 Serum Index Gen.2 COBAS INTEGRA / cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 26, 2024

VENTANA Basal Cell Cocktail (34βE12+p63)

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 22, 2024

ACCU-CHEK Active Control

Manufacturer:

BIONOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 21, 2024

ACCU-CHEK Softclix Lancets

Manufacturer:

HTL-STREFA S.A

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 19, 2024

ACCU-CHEK Safe-T-Pro Uno

Manufacturer:

HTL-STREFA S.A

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 19, 2024

COBAS Elecsys Anti-HAV II cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 13, 2024

COBAS CREJ2 Cretinine Jaffe Gen.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 13, 2024

COBAS ALP2S ALP IFCC Gen.2 Small cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 13, 2024

COBAS Cortisol II CalSet Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 13, 2024

COBAS ACET2 ONLINE TDM Acetaminophen Gen.2 COBAS INTEGRA/ COBAS c sytems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2024

COBAS Progesterone III CalSet Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2024

ACCU-CHEK Softclix Lancets

Manufacturer:

ASAHI POLYSLIDER COMPANY LIMITED

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 8, 2024

PreciControl Anti-HAV II cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 8, 2024

COBAS CalSet AMH Plus Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 8, 2024

COBAS c 111 and Accessories

Manufacturer:

ROCHE DIAGNOSTICS INTL, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 8, 2024

ROCHE CARDIAC POC Troponin T cobas h 232

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 8, 2024

COBAS total PSA CalSet II cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 4, 2024

free PSA CalSet cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 2, 2024

Accu-Chek Instant S mg/dl Set

Manufacturer:

ALTEK MEDICAL (KUNSHAN) LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 31, 2024

COBAS Elecsys Free PSA

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 29, 2024

ELECSYS Total PSA cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 11, 2024

ELECSYS free PSA cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 11, 2024

ELECSYS HE4 Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 9, 2024

VENTANA CONFIRM anti-ALK1 (ALK01) Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 3, 2024

COMBUR 10 Test (SG, pH, LEU, NIT, PRO, GLU, KET, UBG, BIL, ERY/Hb)

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 3, 2024

Elecsys Progesterone III

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 28, 2024

COBAS Elecsys NSE

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 28, 2024

COBAS Elecsys PAPP-A cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 28, 2024

COBAS proBNP II CalSet cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 28, 2024

COBAS BARB ONLINE DAT Barbiturate Plus cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 20, 2024

COBAS ELECSYS RAW Plus

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 19, 2024

ACCU-CHEK Performa Test Strips

Manufacturer:

ROCHE DIABETES CARE, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 7, 2024

COBAS CYSC2 Tina-quant Cystatin C Gen.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2024

COBAS Elecsys AMH Plus

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2024

COBAS Elecsys TSH

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 6, 2024

COBAS FRA Fructosamine cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 6, 2024

COBAS™ COC2 ONLINE DAT Cocaine II cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 6, 2024

Elecsys Total-Tau CSF

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 3, 2024

COBAS p 671 Centrifuge Unit

Manufacturer:

ROCHE DIAGNOSTICS AUTOMATION SOLUTIONS GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 3, 2024

COBAS p 671 Centrifuge Unit

Manufacturer:

ROCHE DIAGNOSTICS AUTOMATION SOLUTIONS GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 31, 2024

B2MG Tina-quant β2-Microglobulin cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 31, 2024

COBAS PreciControl Total-Tau

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 29, 2024

PreciControl Phospho-Tau (181P)

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 27, 2024

COBAS BNZ2 ONLINE DAT Benzodiazepines II cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 27, 2024

ELECSYS Phospho-Tau (181P) CSF

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 27, 2024

ELECSYS Total-Tau CSF

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 27, 2024

COBAS NH3L2 Ammonia II cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 27, 2024

ELECYS Beta-Amyloid (1-42) CSF II

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 21, 2024

AAT2 Tina-quant α1-Antitrypsin ver.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 21, 2024

ASLOT Tina-quant Antistreptolysin O cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 21, 2024

THEO2 ONLINE TDM Theophylline cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 21, 2024

COBAS ACETA Acetaminophen COBAS INTEGRA / cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 21, 2024

Elecsys Phospho-Tau (181P) CSF

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2024

Elecsys Beta-Amyloid (1-42) CSF II

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2024

VENTANA Anti-ERG (EPR3864) Rabbit Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 20, 2024

COBAS HBDH2 α-Hydroxybutyrate Dehydrogenase Gen.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2024

DIG Digoxin COBAS INTEGRA / cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2024

COBAS p 471 Centrifuge Unit

Manufacturer:

ROCHE DIAGNOSTICS AUTOMATION SOLUTIONS GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 20, 2024

VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 16, 2024

VENTANA Anti-P120 Catenin (98) Mouse Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 14, 2024

VENTANA anti-MSH6 (SP93) Rabbit Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 13, 2024

VENTANA anti-MLH1 (M1) Mouse Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 13, 2024

VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 13, 2024

LI Lithium cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 13, 2024

COBAS AAGP2 Tina-quant α1-Acid Glycoprotein Gen.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 13, 2024

COBAS HCYS Homocysteine Enzymatic Assay cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 9, 2024

ALBT2 Tina-quant Albumin Gen.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 8, 2024

GLUC2 Glucose HK cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 8, 2024

SMS Detergent 2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 8, 2024

COBAS PreciControl Beta-Amyloid (1-42) II

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 8, 2024

COBAS e 411 Analyzer (Disk System) and Accessories

Manufacturer:

HITACHI HIGH TECHNOLOGIES CORP.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 8, 2024

COBAS c 311 and Accessories

Manufacturer:

HITACHI HIGH TECHNOLOGIES CORP.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 7, 2024

VENTANA Anti-Cytokeratin 17 (SP95) Rabbit Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 7, 2024

COBAS 4800 System Wash Buffer Kit

Manufacturer:

ROCHE MOLECULAR SYSTEMS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 7, 2024

COBAS Cell Wash Solution II / Acid Wash

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 7, 2024

VENTANA Anti-Epithelial Related Antigen (MOC-31) Mouse Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 3, 2024

COBAS 4800 System Liquid Cytology Preparation Kit

Manufacturer:

ROCHE MOLECULAR SYSTEMS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 3, 2024

VENTANA Anti-Glypican 3 (GC33) Mouse Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 3, 2024

COBAS Control Set DAT I Roche systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 29, 2024

COBAS CERU Ceruloplasmin cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 26, 2024

ACCU-CHEK Performance Control

Manufacturer:

BIONOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 26, 2024

COBAS THC2 ONLINE DAT Cannabinoids II cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 23, 2024

COBAS MPX - 480

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 22, 2024

COBAS c 303 Analytical Unit and Accessories

Manufacturer:

HITACHI HIGH-TECH CORPORATION NAKA DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 18, 2024

COBAS C4-2 Tina-quant Complement C4 ver.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 17, 2024

COBAS® MPX Control Kit

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 16, 2024

COBAS c 503 Analytical Unit and Accessories

Manufacturer:

HITACHI HIGH-TECHNOLOGIES CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 16, 2024

COBAS SnapPak

Manufacturer:

FISHER DIAGNOSTICS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2024

BENCHMARK GX and Accessories

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 4, 2024

ACCU-CHECk Active Set and Accessories

Manufacturer:

SANMINA-SCI (SHENZHEN) LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 3, 2024

COAGUCHEK Softclix Lancet

Manufacturer:

HTL-STREFA S.A

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 28, 2024

COBAS OPI2 ONLINE DAT Opiates II cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 28, 2024

VENTANA ROS1 (SP384) Rabbit Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 25, 2024

COBAS PREA Prealbumin cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 25, 2024

VENTANA HER2 Dual ISH DNA Probe Cocktail

Manufacturer:

VENTANA MEDICAL SYSTEMS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 25, 2024

COBAS AMPS2 ONLINE DAT Amphetamines II cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 25, 2024

COBAS ISE Standard High

Manufacturer:

EVER PHARMA JENA GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 25, 2024

Elecsys Folate III

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 22, 2024

VENTANA DP 200 and Accessories

Manufacturer:

FFEI LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 22, 2024

IGA-C Tina-quant IgA CSF cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 22, 2024

COBAS HAPT2 Tina-quant Haptoglobin ver.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 21, 2024

COBAS UIBC Unsaturated Iron-Binding Capacity cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 21, 2024

COBAS ISE Standard Low

Manufacturer:

EVER PHARMA JENA GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 19, 2024

COBAS CalSet B-Amyloid (1-42) II

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 19, 2024

COBAS CalSet Phospho-Tau (181P)

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 19, 2024

COBAS u 411 and Accessories

Manufacturer:

ROCHE DIAGNOSTICS INTERNATIONAL LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 18, 2024

COBAS 6800 Systems

Manufacturer:

ROCHE DIAGNOSTICS INTERNATIONAL LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 18, 2024

ACCU-CHEK Inform II Meter Kit + RF and Accessories

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 15, 2024

CHE2 Cholinesterase Gen.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 15, 2024

LACT2 Lactate Gen.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 13, 2024

BenchMark ULTRA PLUS Instrument

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 13, 2024

COBAS p 471 Centrifuge Unit

Manufacturer:

ROCHE DIAGNOSTICS AUTOMATION SOLUTIONS GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 13, 2024

COBAS Elecsys Ferritin

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 8, 2024

VENTANA DP 600 slide scanner

Manufacturer:

CARL ZEISS CMP GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 8, 2024

Elecsys Folate III

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 8, 2024

COBAS Elecsys C-Peptide

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 8, 2024

COBAS e 801 Analytical Unit and Accessories

Manufacturer:

HITACHI HIGH-TECHNOLOGIES CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 7, 2024

COBAS 5800 System and Accessories

Manufacturer:

ROCHE DIAGNOSTICS INTERNATIONAL LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 5, 2024

COBAS C3C-2 Tina-quant Complement C3c ver.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 5, 2024

COBAS ACP2 Acid Phosphatase Gen.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 5, 2024

DIBU Dibucaine Cobas C Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 5, 2024

OPI 2 ONLINE DAT Opiates II cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 1, 2024

COBAS IGM-C Tina-quant IgM CSF cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 1, 2024

COBAS ELECSYS CYFRA 21-1

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 29, 2024

COBAS 8000 ISE 900 Module and Accessories

Manufacturer:

HITACHI HIGH TECHNOLOGIES CORP.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 28, 2024

COBAS Calset Folate

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 28, 2024

COBAS Control Set DAT II Roche systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 28, 2024

COBAS Elecsys Folate lll Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 27, 2024

RF-II Rheumatoid Factors II cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 27, 2024

COBAS Diluents Universal

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 27, 2024

COBAS HIV-1 Nucleic Acid Test for Use on The Cobas 4800 System

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 26, 2024

COBAS 4800 MRSA/SA Controls and Cofactor Kit (c4800 MRSA/SA CTLS/COFR)

Manufacturer:

ROCHE MOLECULAR SYSTEMS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 25, 2024

ELECSYS HCG+β Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 25, 2024

COBAS Folate III Calset

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 21, 2024

COBAS 4800 MRSA/SA Amplification/Detection Kit (c4800 MRSA/SA AMP/DET)

Manufacturer:

ROCHE MOLECULAR SYSTEMS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 17, 2024

COBAS Elecsys FT4 III cobas e 801 analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 13, 2024

COBAS 4800 Cdiff Amplification/Detection Kit (c4800 CDIFF AMP/DET)

Manufacturer:

ROCHE MOLECULAR SYSTEMS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 13, 2024

COBAS Specimen Pre-Extraction Reagent

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 9, 2024

COBAS Control Set DAT III Roche Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 7, 2024

LDLC3 LDL-Cholesterol Gen.3 cobas c 111

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 7, 2024

COBAS Elecsys Anti-TSHR cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2024

LDLC3 LDL-Cholesterol Gen.3 COBAS INTEGRA / cobas

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2024

COBAS 4800 Cdiff Controls and Cofactor Kit (c4800 CDIFF CTLS/COFR)

Manufacturer:

ROCHE MOLECULAR SYSTEMS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2024

COBAS 4800 HPV Controls Kit

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 2, 2024

COBAS 4800 HPV Amplification/Detection Kit

Manufacturer:

ROCHE MOLECULAR SYSTEMS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 1, 2024

ETOH 2 Ethanol Gen.2 COBAS INTEGRA / cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2024

COBAS 4800 System Sample Preparation Kit

Manufacturer:

ROCHE MOLECULAR SYSTEMS.INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 1, 2024

COBAS BARB ONLINE DAT Barbiturates Plus cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2024

ACCU-CHEK Instant Set Wireless Blood Glucose Meter and Lancing Device

Manufacturer:

ALTEK MEDICAL (KUNSHAN) LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 27, 2024

ACCU-CHEK Instant Wireless Blood Glucose Meter Only

Manufacturer:

ALTEK MEDICAL (KUNSHAN) LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 24, 2024

SPECIFIES THAT Plus 1 Roche Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 22, 2024

COBAS Activator Cobas Integra cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 18, 2024

ELECSYS Anti-TSHR cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 18, 2024

COBAS CalSet Anti-TSHR cobas and analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 12, 2024

ELECSYS TSH cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 12, 2024

COBAS TSH CalSet cobas e analyzer

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 12, 2024

ELECSYS TSH cobas e analyzer

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 11, 2024

ELECSYS CA 19-9

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 5, 2024

ELECSYS CA 15-3 II

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 5, 2024

COAGUCHEK INRange System

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 28, 2023

ELECSYS DIGIT 21-1

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 28, 2023

ELECSYS CA 15-3 II

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 28, 2023

ROCHE CARDIAC POC NT proBNP Control

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2023

COBAS Calset PTH

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2023

COBAS Calset II PTH

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2023

Elecsys PTH

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2023

COBAS PreciControl HCV Duo

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 21, 2023

COAGUCHEK XS PT Test

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 21, 2023

COBAS PreciControl Rubella IgG Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 19, 2023

ELECSYS HCV Duo

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 19, 2023

COBAS Elecsys Insulin

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 18, 2023

COBAS PreciControl HBsAg II quant II Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 18, 2023

COBAS Elecsys Estradiol III

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 18, 2023

Roche CARDIAC POC NT-proBNP

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 18, 2023

COBAS Elecsys sFlt-1 Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 17, 2023

COBAS Elecsys Rubella IgG Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 14, 2023

ETOH2 Ethanol Gen.2 cobas c system

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 14, 2023

TRIGL cobas c 111 Triglycerides

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 14, 2023

COBAS PreciControl HBsAg II Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 14, 2023

COBAS Elecsys Cortisol II Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 14, 2023

COBAS VANC3 ONLINE TDM Vancomycin Gen.3 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 14, 2023

COBAS PHNY2 ONLINE TDM Phenytoin cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 13, 2023

Combur10 Test M

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 13, 2023

VENTANA Anti-CD8 (SP239) Rabbit Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 13, 2023

COBAS UA2 cobas c 111 Uric acid ver.2

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 13, 2023

COBAS PreciControl Rubella IgM Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 13, 2023

COBAS UA2 Uric Acid ver.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 8, 2023

COBAS PreClean M Modular Analytics E170, cobas e 601 and cobas e 602 analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 8, 2023

COBAS ProCell M Modular Analytics E170, cobas e 601 and cobas e 602 analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 8, 2023

COBAS Elecsys Rubella IgM Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 8, 2023

COBAS CleanCell Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 5, 2023

COBAS GLUC3 Glucose HK Gen.3 Cobas Integra cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 5, 2023

COBAS PYP cobas c 111 Pyridoxal Phosphate

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 4, 2023

COBAS AAT2 Tina-quant α1 - Antitrypsin ver.2

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 4, 2023

COBAS Elecsys IgE II Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 4, 2023

COBAS IRON2 Iron Gen.2 Cobas Integra cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 4, 2023

COBAS GGT-2 cobas c 111 y-Glutamyltransferase ver.2

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 2, 2023

ASTL cobas c 111 Aspartate Aminotransferase

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 2, 2023

COBAS ISE Calibration Kit cobas c 111

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 2, 2023

COBAS PreciControl Toxo IgM Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 30, 2023

CHE2 Cholinesterase Gen.2 Cobas Integra / cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 30, 2023

VENTANA Anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 29, 2023

COBAS Elecsys Rubella IgM cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 29, 2023

GLUC2 cobas c 111 Glucose HK

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 29, 2023

ProCell Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 29, 2023

ACCU-CHEK® Instant Wireless Blood Glucose Meter and Lancing Device

Manufacturer:

ROCHE DIABETES CARE., INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 28, 2023

COBAS CREP2 cobas c 111 Creatinine plus ver.2

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 27, 2023

COBAS ALB2 cobas c 111 Albumin Gen.2

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 27, 2023

COBAS C.f.a.s. HbA1c Calibrator for automated systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 27, 2023

COBAS Elecsys PlGF Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 27, 2023

COBAS Elecsys Syswash Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 27, 2023

COBAS TP2 cobas c 111 Total Protein Gen.2

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 27, 2023

COBAS CHOL2 cobas c 111 Cholesterol Gen.2

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 27, 2023

COBAS AAGP2 Tina-quant a1-Acid Glycoprotein Gen.2 COBAS INTEGRA / cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 23, 2023

COBAS ALP2S cobas c 111 Alkaline Phosphatase acc. To IFC Gen.2

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 23, 2023

COBAS UREAL cobas c 111 Urea/BUN

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 23, 2023

ACCU-CHEK Guide Set Wireless Blood Glucose Meter and Lancing Device

Manufacturer:

SANMINA CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 23, 2023

COBAS AMYL2 cobas c 111 α-Amylase EPS ver.2

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 23, 2023

COBAS PreciControl Cortisol Saliva Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 23, 2023

COBAS Estradiol III CalSet Elecsys and cobas e analyzer

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 21, 2023

COBAS PreciSet TDM II Roche Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 21, 2023

COBAS Estradiol III Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 21, 2023

COBAS C.f.a.s. IgA/IgM CSF Roche Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 21, 2023

COBAS CA 125 II CalSet II Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 17, 2023

COBAS SALI Salicylate cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 16, 2023

COBAS C.f.a.s. PAC Roche Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 16, 2023

PHNO2 ONLINE TDM Phenobarbital cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 16, 2023

Accu-Chek Guide Wireless Blood Glucose Meter Only

Manufacturer:

SANMINA-SCI INDIA PVT LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 16, 2023

COBAS Elecsys CA 125 II Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 16, 2023

COAGUCHEK XS PT Test PST

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 14, 2023

DIG ONLINE TDM Digoxin cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 13, 2023

COMBUR10 Test M

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 13, 2023

ROCHE Urisys 1100 Urine Analyzer and Accessories

Manufacturer:

77 ELECTRONICS INSTRUMENT INDUSTRY LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2023

COBAS MG2 Magnesium Gen.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2023

IGG-2 Tina-quant IgG Gen.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2023

COBAS TRSF2 Tina-quant Transferrin ver.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2023

COMBUR3 Test

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 8, 2023

COBAS CARB4 ONLINE TDM Carbamazepine Gen.4 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2023

VENTANA Silver ISH DNP Detection Kit

Manufacturer:

VENTANA MEDICAL SYSTEMS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 8, 2023

COMBUR 10 Test UX

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 8, 2023

COBAS U Pack

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 8, 2023

VENTANA Red ISH DIG Detection Kit

Manufacturer:

VENTANA MEDICAL SYSTEM INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 6, 2023

ULTRA Cell Conditioning Solution (ULTRA CC1)

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 4, 2023

ULTRA LCS (Predilute)

Manufacturer:

VENTANA MEDICAL SYSTEMS INC., USA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 4, 2023

ULTRA Cell Conditioning Solution (ULTRA CC2)

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 2, 2023

COBAS TOXO IgG Avidity Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 31, 2023

COBAS Elecsys Toxo IgG Avidity cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 31, 2023

COBAS Elecsys Toxo IgM cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 31, 2023

Acid Wash cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 31, 2023

Elecsys IgE II

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 31, 2023

COBAS PreciControl Toxo IgG Avidity Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 31, 2023

ISETROL Level 1, 2, 3

Manufacturer:

BIONOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2023

COMBITROL Plus B Level 1

Manufacturer:

BIONOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2023

COMBITROL Plus B Level 2

Manufacturer:

BIONOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 20, 2023

COBAS Elecsys IgE II

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 20, 2023

COAGUCHEK XS PT Controls

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 19, 2023

COBAS FERR4 Tina-quant Ferritin Gen.4 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 13, 2023

ELECSYS HE4

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 13, 2023

COBAS IGA-2 Tina-quant IgA Gen.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 13, 2023

IGM-2 Tina-quant IgM Gen.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 13, 2023

COBAS ACET2 ONLINE TDM Acetaminophen Gen.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 13, 2023

START Antigen Excess Reagent cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 12, 2023

COBAS PYP Pyridoxal phosphate cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 11, 2023

SCCS Special Cell Cleaning Solution cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 10, 2023

SI2 Sample Index Gen.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 10, 2023

COBAS A1CD Hemolyzing reagent cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 9, 2023

ELECSYS CA 125 II

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 9, 2023

ELECSYS CA 125 II

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 9, 2023

COBAS NACL Diluent NaCl 9% cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 9, 2023

ELECSYS CA 19-9

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 9, 2023

CRPHS Cardiac C-Reactive Protein (Latex) High Sensitive cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 4, 2023

ECO-D EcoTergent cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 4, 2023

FSH Calset II

Manufacturer:

ROCHE DIAGNOSTIC GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 26, 2023

AMY-P alfa-Amylase EPS Pancreatic cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 26, 2023

LH Calset II

Manufacturer:

ROCHE DIAGNOSTIC GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 26, 2023

COBAS ALP2 Alkaline Phosphatase acc. to IFCC Gen.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 24, 2023

NAOHD Detergent 1 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 22, 2023

COBAS ALTP Alanine Aminotransferase PyP cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 20, 2023

COBAS u pack cobas u 601 analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 20, 2023

COBAS u Calibration Strip

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 20, 2023

AMYL2 alpha-Amylase EPS ver.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 18, 2023

Basic Wash cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 15, 2023

Ventana Anti-PRAME (EPR20330) Rabbit Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 7, 2023

Ventana PTEN (SP218) Rabbit Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 7, 2023

CKMB Creatine Kinase-MB cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 28, 2023

ASTP Aspartate Aminotransferase PyP cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2023

COBAS UREAL Urea/BUN cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 18, 2023

COBAS PreciControl Universal Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 14, 2023

COBAS CK Creatine Kinase cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 9, 2023

COBAS LDHI2 Lactate Dehydrogenase acc. To IFCC ver.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 9, 2023

GGT-2 Gamma-Glutamyltransferase ver.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 7, 2023

TRIGL Triglycerides cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 7, 2023

PHOS2 Phosphate (Inorganic) ver.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 3, 2023

TPUC3 Total Protein Urine/CSF Gen.3 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 1, 2023

ACCU-CHEK Safe-T-Pro Uno

Manufacturer:

ROCHE DIABETES CARE GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 28, 2023

COBAS® GLU test strips

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 27, 2023

COBAS LDLC3 LDL-Cholesterol Gen.3 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 26, 2023

ACCU-CHEK Softclix

Manufacturer:

ROCHE DIABETES CARE GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 25, 2023

HDLC4 HDL-Cholesterol Gen.4 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 24, 2023

COBAS Elecsys Progesterone Diluent

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 20, 2023

COBAS Control Set DAT Clinical

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 18, 2023

COBAS sTfR Control Set Roche Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 18, 2023

Cobas® GLU QC Kit

Manufacturer:

BIONOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 17, 2023

COBAS CREJ2 Creatinine Jaffe Gen.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 12, 2023

GLUC3 Glucose HK Gen.3 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 12, 2023

VENTANA INFORM EBER (Epstein-Barr Virus Early RNA) Probe

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 12, 2023

ACCU-CHEK Performa and Accessories

Manufacturer:

SANMINA-SCI INDIA PVT LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 12, 2023

CHOL2 Cholesterol Gen.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 11, 2023

APOAT Tina-quant Apolipoprotein A-1 ver.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 11, 2023

ACCU-CHEK FastClix Lancets

Manufacturer:

GERRESHEIMER REGENSBURG, GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 10, 2023

COBAS® SARS-CoV-2 Qualitative Control Kit

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 9, 2023

COBAS A1CX3 Tina-quant Hemoglobin A1cDx Gen.3 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 9, 2023

COBAS SARS-CoV-2 & Influenza A/B Control Kit

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 9, 2023

COBAS LIPC Lipase colorimetric cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 6, 2023

COBAS APOBT Tina-quant Apolipoprotein B ver.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 6, 2023

COBAS® SARS-CoV-2 Qualitative

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 4, 2023

COBAS PCR Media Dual Swab Sample Kit

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 3, 2023

COBAS® MTB-RIF/INH Positive Control Kit

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 30, 2023

Cobas PCR Urine Sample Kit

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 30, 2023

cobas MTB Positive Control Kit

Manufacturer:

ROCHE MOLECULAR SYSTEM, INC., USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 26, 2023

COBAS SARS-CoV-2 & Influenza A/B

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 22, 2023

Cobas b 123 (2) POC System

Manufacturer:

ROCHE DIAGNOSTICS INTERNATIONAL LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 21, 2023

COBAS b 123 < 1 > POC System

Manufacturer:

ROCHE DIAGNOSTICS INTERNATIONAL LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 21, 2023

COBAS® BKV

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 17, 2023

WINDOW 10X SSC

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 16, 2023

CO2-L Bicarbonate Liquid cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 16, 2023

VENTANA Reaction Buffer Concentrate (10X)

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 16, 2023

COBAS Preciset sTfR Roche Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 16, 2023

COBAS CREP2 Creatinine plus ver.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 16, 2023

LCS (Predilute)

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 13, 2023

ULTRA LCS (Predilute)

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 13, 2023

COBAS ALB2 Albumin Gen.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 9, 2023

COBAS TP2 Total Protein Gen.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 9, 2023

COBAS CA2 Calcium Gen.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 9, 2023

COBAS BILT3 Bilirubin Total Gen.3 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 9, 2023

COBAS LIPC Lipase colorimetric cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 9, 2023

COBAS Urine Diluent

Manufacturer:

ROCHE DIAGNOSTICS INTERNATIONAL LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 6, 2023

COBAS LDHI2 Lactate Dehydrogenase acc. TO IFCC ver.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 4, 2023

COBAS Tg II CalSet Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 4, 2023

BENCHMARK XT AND Accessories

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 1, 2023

COBAS MAI Positive control kit

Manufacturer:

ROCHE MOLECULAR SYSTEM, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 1, 2023

cobas MAY

Manufacturer:

ROCHE MOLECULAR SYSTEM, INC., USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 30, 2023

Cobas® MTB-RIF/INH

Manufacturer:

ROCHE MOLECULAR SYSTEM, INC., USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 29, 2023

COBAS 5800 System and Accessories

Manufacturer:

ROCHE DIAGNOSTICS INTERNATIONAL LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 28, 2023

VENTANA Confirm anti-Topoisomerase II Alpha (JS5B4) Rabbit Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 25, 2023

VENTANA UltraView Silver Wash II

Manufacturer:

VENTANA MEDICAL SYSTEMS.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 24, 2023

CalSet IGFBP-3

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 23, 2023

VENTANA Confirm Anti-Ki-67 (30-9) Rabbit Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 23, 2023

VENTANA Confirm anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 23, 2023

COBAS CalSet FT4 III Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 23, 2023

VENTANA Cell Conditioning Solution (CC1)

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 22, 2023

COBAS MTB

Manufacturer:

ROCHE MOLECULAR SYSTEM, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2023

VENTANA Antibody Diluent

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 20, 2023

COBAS® Microbial Inactivation Solution

Manufacturer:

ROCHE DIAGNOSTICS GMBH. CENTRALISED AND POINT OF CARE SOLUTIONS

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 20, 2023

VENTANA CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 20, 2023

VENTANA LCS (Predilute)

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 20, 2023

VENTANA Amplification Kit

Manufacturer:

VENTANA MEDICAL SYSTEMS.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 20, 2023

VENTANA CONFIRM anti-Vimentin (V9) Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 17, 2023

VENTANA PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 16, 2023

VENTANA Cell Conditioning Solution (CC2)

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 16, 2023

VENTANA Reaction Buffer Concentrate (10X)

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.,

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 12, 2023

WINDOW Hematoxylin II

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 12, 2023

VENTANA ISH Protease 1

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 12, 2023

VENTANA ISH Protease 2

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 12, 2023

VENTANA Protease 3

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 10, 2023

VENTANA EZ Prep Concentrate (10X)

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 10, 2023

COBAS b 123 (4) POC System

Manufacturer:

ROCHE DIAGNOSTICS INTERNATIONAL LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 5, 2023

ACCU-CHEK FastClix Lancets

Manufacturer:

WEIDMANN MEDICAL TECHNOLOGY AG

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 5, 2023

Combur 10 Test M

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 5, 2023

COBAS NAOHD Detergent 1 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 4, 2023

COBAS SMS Detergent 2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 28, 2023

COBAS Sample Cleaner 2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 28, 2023

Sample Cleaner 1 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 28, 2023

ELECSYS FT4 IV

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 25, 2023

COBAS KAPP2

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 20, 2023

PreciControl HCC V2

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 20, 2023

Reference Electrode COBAS INTEGRA ISE Modules

Manufacturer:

ROCHE DIAGNOSTICS INTL, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 20, 2023

CALSET GDF-15

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 20, 2023

Cobas HIV-1/HIV-2 Qualitative

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 18, 2023

VENTANA CONFIRM anti-Calretinin (SP65) Rabbit Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 6, 2023

VENTANA anti-CD43 (L60) Mouse Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 6, 2023

Cl- Electrode COBAS INTEGRA ISE Modules

Manufacturer:

ROCHE DIAGNOSTICS INTL, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2023

cobas EBV/BKV Control Kit

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 4, 2023

Cobas® EBV

Manufacturer:

ROCHE MOLECULAR SYSTEM, INC., USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 4, 2023

VENTANA CONFIRM anti-EMA (E29) Mouse Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 3, 2023

VENTANA HE 600 Systems and Accessories

Manufacturer:

Ventana Medical Systems Inc.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 3, 2023

COBAS D-DI2 Tina-quant D-Dimer Gen.2 Cobas Integra / Cobas c Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 31, 2023

COAGUCHEK XS System AND Accessories

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 30, 2023

COBAS Roche Cardiac proBNP+

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 30, 2023

cobas HPV

Manufacturer:

ROCHE MOLECULAR SYSTEM, INC., USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 29, 2023

ELECSYS FT4 III Elecsys and cobas e analyzer

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 28, 2023

Na+ Electrode COBAS INTEGRA ISE Modules

Manufacturer:

ROCHE DIAGNOSTICS INTL, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 27, 2023

COBAS® PCR Media Dual Swab Sample Kit

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 27, 2023

cobas HPV Positive control Kit

Manufacturer:

ROCHE MOLECULAR SYSTEM, INC., USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 27, 2023

K+ Electrode COBAS INTEGRA ISE Modules

Manufacturer:

ROCHE DIAGNOSTICS INTL, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 26, 2023

COBAS HbA1c Test cobas b 101

Manufacturer:

PANASONIC HEALTHCARE CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 24, 2023

COBAS Elecsys Toxo IgM Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 24, 2023

COBAS BILT3 Bilirubin Total Gen.3 cobas c 111

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 24, 2023

COBAS CalSet II PTH cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 22, 2023

Elecsys Toxo IgG Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 22, 2023

COBAS PreciControl Toxo IgG Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 22, 2023

Elecsys PIVKA-II cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 22, 2023

COBAS NH3L cobas c 111 Ammonia

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 16, 2023

COBAS 6000 c 501 and Accessories

Manufacturer:

HITACHI HIGH TECHNOLOGIES CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 16, 2023

COBAS PreciControl Active B12

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 10, 2023

COBAS ALP2 Alkaline Phosphatase acc to IFCC Gen.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 10, 2023

COBAS IGM-C Tina-quant IgM CSF cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 10, 2023

COBAS AST Aspartate Aminotransferase cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GmbH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 10, 2023

COBAS C.f.a.s (Calibrator FOR automated systems)

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 10, 2023

VENTANA CONFIRM anti-CD99 (O13) Mouse Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 10, 2023

CINTEC p16 Histology

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 10, 2023

COBAS CT/NG Positive Control Kit

Manufacturer:

ROCHE MOLECULAR SYSTEM, INC., USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 7, 2023

COBAS TV/MG

Manufacturer:

ROCHE MOLECULAR SYSTEM, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 7, 2023

cobas CT/NG

Manufacturer:

ROCHE MOLECULAR SYSTEM, INC., USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 6, 2023

Cobas Plasma Separation Card

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 6, 2023

COBAS Testosterone II CalSet II Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 3, 2023

COBAS CRPHS Cardiac C Reactive Protein (Latex) High Sensitive Cobas Integra / Cobas c Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 2, 2023

COBAS D-Dimer Gen.2 Control I/II

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 2, 2023

COBAS TV/MG Positive Control Kit

Manufacturer:

ROCHE MOLECULAR SYSTEM, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 2, 2023

COBAS D-Dimer Gen.2 Calibrator SET Roche Systems

Manufacturer:

ROCHE DIAGNOSTICS GmbH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 2, 2023

VENTANA Bluing Reagent

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 1, 2023

VENTANA Hematoxylin

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 1, 2023

VENTANA ISH Protease 3

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 1, 2023

VENTANA OptiView Amplification Kit

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 26, 2023

VENTANA UltraView Universal DAB Detection Kit

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 26, 2023

VENTANA Rabbit Monoclonal Negative Control Ig

Manufacturer:

VENTANA MEDICAL SYSTEM INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 24, 2023

CalSet Active B12

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 23, 2023

ACCU-CHEK FastClix Lancing Device

Manufacturer:

BALDA MEDICAL GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 20, 2023

VENTANA OptiView DAB IHC Detection Kit

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 17, 2023

COBAS MTB Positive Control Kit for use on the cobas 6800/8800 Systems

Manufacturer:

ROCHE MOLECULAR SYSTEMS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 17, 2023

WINDOW 10X SSC

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 17, 2023

VENTANA CONFIRM anti-Kappa Rabbit Polyclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 17, 2023

COBAS ACTH Calset Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 16, 2023

COBAS MTB Nucleic acid test for use on the cobas 6800/8800 Systems

Manufacturer:

ROCHE MOLECULAR SYSTEMS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 15, 2023

COBAS Elecsys Prolactin II Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 10, 2023

VENTANA CONFIRM anti-CD34 (QBEnd/10) Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 9, 2023

COBAS Elecsys ACTH Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 9, 2023

COBAS Elecsys Anti-HCV II cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 8, 2023

COBAS AMYL 2 a-Amylase EPS ver.2 COBAS INTEGRA / Cobas c Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 7, 2023

COBAS FERR4 Tina-quant Ferritin Gen.4 Cobas c Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 7, 2023

VENTANA CONFIRM anti-Prostate Specific Antigen (PSA) Rabbit Polyclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 7, 2023

COBAS Prolactin II Calset Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 30, 2023

VENTANA CONFIRM anti-Keratin (34βE12) Mouse Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 25, 2023

COBAS Sodium Electrode Conditioner

Manufacturer:

ROCHE DIAGNOSTICS INTL, LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 27, 2022

VENTANA Confirm anti-Synaptophysin (SP11) Rabbit Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 19, 2022

VENTANA anti-Cytokeratin 5/6 (D5/16B4) Mouse Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 19, 2022

COBAS ProGRP CalSet

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 15, 2022

COBAS PreciControl HbA1c norm

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 8, 2022

VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 8, 2022

COBAS Elecsys FT3 III Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 8, 2022

VENTANA CONFIRM anti-CD15 (MMA) Mouse Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 8, 2022

COBAS Lipid Panel CHOL-TRIGL-HDL-LDL cobas b 101

Manufacturer:

PHC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 6, 2022

COBAS UIBC Unsaturated Iron-Binding Capacity Cobas c Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 6, 2022

COBAS ALB2 Albumin Gen.2 Cobas c Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 6, 2022

COBAS Elecsys HIV Combi PT Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 6, 2022

COBAS® HBV/HCV/HIV-1 Control Kit for Cobas 6800/8800

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 30, 2022

CINTEC PLUS Cytology Kit

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 30, 2022

COBAS UA2 Uric Acid ver.2 Cobas C Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 30, 2022

COBAS Elecsys Syphilis Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 25, 2022

COBAS AMPII ONLINE DAT Amphetamines II Cobas Integra

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 25, 2022

COBAS Elecsys Tacrolimus Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 18, 2022

COBAS Cyclosporine CalSet Elecsys and Cobas e Analyzer

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 18, 2022

COBAS PreciControl Syphilis Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 18, 2022

COBAS PreciControl HSV Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 18, 2022

VENTANA anti-c-MYC (Y69) Rabbit Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 16, 2022

COBAS Cystatin C Control Set Gen.2 Roche systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 14, 2022

ROCHE Elecsys Cyclosporine Elecsys and cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 14, 2022

COBAS Elecsys Calcitonin Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2022

COBAS Elecsys BRAHMS PCT cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 7, 2022

COBAS Z 480 and Accessories

Manufacturer:

ROCHE DIAGNOSTICS INTL, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 7, 2022

COBAS PreciControl ClinChem Multi 2 Roche Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 7, 2022

COBAS CYSC2 Tina-quant Cystatin C Gen.2 COBAS INTEGRA / Cobas C Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 7, 2022

COBAS PreciControl HbA1c Path Roche Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 7, 2022

VENTANA anti-CD30 (Ber-H2) Mouse Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 1, 2022

VENTANA anti-Thyroid Transcription Factor-1 (SP141) Rabbit Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 31, 2022

VENTANA CONFIRM anti-CD8 (SP57) Rabbit Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 31, 2022

COBAS Homocysteine Calibrator Kit

Manufacturer:

DIAZYME LABORATORIES.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2022

VENTANA anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2022

VENTANA CONFIRM anti-Cytokeratin 7 (SP52) Rabbit Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 27, 2022

VENTANA anti-bcl-2 (SP66) Rabbit Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 27, 2022

VENTANA CONFIRM anti-bcl-2 (124) Mouse Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2022

VENTANA Basal Cell Cocktail (34 Beta E12+p63)

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 24, 2022

VENTANA CONFIRM anti-CD4 (SP35) Rabbit Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 24, 2022

VENTANA Confirm Anti-Cytokeratin 20 (SP33) Rabbit Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 20, 2022

VENTANA CONFIRM anti-CD5 (SP19) Rabbit Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 20, 2022

VENTANA CONFIRM anti-PAX5 (SP34) Rabbit Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 19, 2022

VENTANA anti-p40 (BC28) Mouse Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 18, 2022

VENTANA CONFIRM anti-Desmin (DE-R-11) Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 18, 2022

VENTANA anti-CD7 (SP94) Rabbit Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 18, 2022

COBAS 6800 Systems

Manufacturer:

ROCHE DIAGNOSTICS INTERNATIONAL LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 11, 2022

COBAS IL-6 CalSet Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 6, 2022

COBAS HBDH2 COBAS INTEGRA / Cobas c Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 6, 2022

COBAS TROPONIN T hs STAT CalSet Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 6, 2022

COBAS ALBT2 cobas c 111 Tina-quant

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 6, 2022

COBAS LPA2 Tina-quant Lipoprotein (a) Gen.2 COBAS INTEGRA / Cobas c Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 6, 2022

COBAS PreciControl ISD Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 6, 2022

COBAS PreciControl ThyroAB Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 28, 2022

COBAS AMPS2 ONLINE DAT Amphetamines II Cobas c Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 26, 2022

COBAS PreciControl ClinChem Multi 1 Roche Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 26, 2022

COBAS MPX Multiplex HIV, HCV & HBV nucleic acid test for use on the cobas 6800/8800 Systems

Manufacturer:

ROCHE MOLECULAR SYSTEM, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 21, 2022

Elecsys ProGRP Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 20, 2022

COBAS Preciset Lp(a) Gen.2

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 19, 2022

COBAS NaCl Diluent 9% cobas c 111

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 16, 2022

COBAS CalSet PTH Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 16, 2022

COBAS ALB2 Albumin Gen.2 COBAS INTEGRA / Cobas c Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 16, 2022

COBAS CRP T Control N Roche Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 16, 2022

COBAS Serum Proteins T Standard Roche Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 12, 2022

COBAS HbA1c Control

Manufacturer:

CANTERBURY SCIENTIFIC LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 12, 2022

COBAS Clean Cobas c 111

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 12, 2022

COBAS Tacrolimus CalSet Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 12, 2022

COBAS PreciControl Lp(a) Gen.2 Roche Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 12, 2022

COBAS BILT3 Bilirubin Total Gen.3 COBAS INTEGRA / Cobas c Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 12, 2022

COBAS PreciControl Growth Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 8, 2022

COBAS® CMV Control Kit

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 8, 2022

COBAS ISD Sample Pretreatment Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 1, 2022

VENTANA Confirm anti-CD20 (L26) Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 29, 2022

VENTANA Confirm anti-p53 (DO-7) Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2022

VENTANA CONFIRM anti-S100 (4C4.9) Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 25, 2022

VENTANA CONFIRM anti-CD45, LCA (RP2/18) Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 25, 2022

VENTANA PD-L1 (SP263) Assay

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 25, 2022

VENTANA Anti-Pan Keratin (AE1/AE3/PCK26) Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 23, 2022

VENTANA Confirm anti-CD3 (2GV6) Rabbit Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 23, 2022

VENTANA PD-L1 (SP142) Assay

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 23, 2022

COBAS STFR2 Tina-quant Soluble Transferrin Receptor II cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2022

MagNA Pure DNA Tissue Lysis Buffer

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2022

COBAS MPX Control Kit Positive Control Kit for Use on The Cobas 6800/8800 Systems

Manufacturer:

ROCHE MOLECULAR SYSTEM, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 16, 2022

COBAS CalSet IGF-1 Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 11, 2022

ACCU-CHEK Active Test Strips

Manufacturer:

ROCHE DIABETES CARE GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 9, 2022

cobas SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas Liat Systems

Manufacturer:

ROCHE MOLECULAR SYSTEMS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 9, 2022

ACCU-CHEK Linearity Test Kit

Manufacturer:

BIONOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 5, 2022

COBAS Precicontrol HIV Gen II Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 4, 2022

ROCHE Cell Collection Medium Kit

Manufacturer:

TERMO FISHER SCIENTIFIC INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 27, 2022

cobas SARS-CoV-2 & Influenza A/B Quality Control Kit for use on the cobas Liat Systems

Manufacturer:

ROCHE MOLECULAR SYSTEMS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 22, 2022

SD BIOSENSOR SARS-CoV-2 Rapid Antigen Test

Manufacturer:

SD BIOSENSOR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 22, 2022

COBAS® PCR Media Uni Swab Sample kit

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 22, 2022

COBAS Ammonia/Ethanol/CO2 Control Abnormal Roche Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 18, 2022

COBAS Elecsys Digoxin cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 14, 2022

Elecsys HSV-1 IgG cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 1, 2022

COBAS HBV

Manufacturer:

ROCHE MOLECULAR SYSTEMS

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 27, 2022

COBAS Elecsys Anti-HBc IgM cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 27, 2022

COBAS NHP Negative Control Kit

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 23, 2022

COBAS IRON2 cobas c 111 Iron Gen.2

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 23, 2022

CELL WASH Solution I / NAOH-D Roche/ Hitachi

Manufacturer:

TERMO FISHER SCIENTIFIC (SUZHOU) INSTRUMENTS CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 22, 2022

COBAS Elecsys PIGF Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 21, 2022

COBAS Homocysteine Control Kit

Manufacturer:

DIAZYME LABORATORIES.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 21, 2022

VENTANA anti-CD117 (EP10) Rabbit Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 21, 2022

CleanCell M MODULAR ANALYTICS E170 and cobas e analyzers

Manufacturer:

TERMO FISHER SCIENTIFIC (SUZHOU) INSTRUMENTS CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 21, 2022

COBAS CA2 Calcium Gen.2 cobas c111

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 21, 2022

ELECSYS Active B12 cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 17, 2022

MagNA Pure 96 Instrument and Accessories

Manufacturer:

ROCHE DIAGNOSTICS INTERNATIONAL LTD.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 14, 2022

COBAS Folate RBC CalSet Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 13, 2022

COBAS Elecsys Anti-HBc II cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 10, 2022

COBAS Elecsys Anti-HBe cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 1, 2022

COBAS Elecsys HCG STAT cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 30, 2022

COBAS PreciControl CMV IgG Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 30, 2022

COBAS PreciControl CMV IgM Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 30, 2022

COBAS b 101 and Accessories

Manufacturer:

PANASONIC HEALTHCARE CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 25, 2022

COBAS Elecsys HBeAg cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 25, 2022

COBAS Roche Cardiac Poc Troponin T 2-Level Control Cobas h 232

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 24, 2022

COBAS MG2 Magnesium Gen.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 22, 2022

ACCUTREND Cholesterol

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 22, 2022

COBAS HIV-1 Quantitative nucleic acid test

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 20, 2022

COBAS IGA Tina-quant Immunoglobulin A Cobas Integra

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2022

Cobas HCV (192 T)

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 20, 2022

COBAS IGM Tina-quant Immunoglobulin M Cobas Integra

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 19, 2022

COBAS IGGT Tina-quant Immunoglobulin G (Turbidimetric) Cobas Integra

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 19, 2022

COBAS Elecsys HSV-2 IgG cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 17, 2022

COBAS Elecsys HSV-1 IgG cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 17, 2022

COBAS PreciControl Troponin Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 16, 2022

COBAS Precicontrol Multimarker Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 16, 2022

Elecsys Folate RBC Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 12, 2022

COBAS sFlt-1 CalSet cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 12, 2022

ACCU-CHEK Inform II

Manufacturer:

ROCHE DIABETES CARE, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 29, 2022

COBAS PreciControl Maternal Care cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 28, 2022

COBAS PIGF CalSet Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 28, 2022

COBAS Elecsys Anti-HBc II cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 27, 2022

COBAS Elecsys Troponin T hs STAT cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 25, 2022

COBAS CalSet Troponin T hs cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 19, 2022

COBAS Elecsys Digitoxin cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 13, 2022

COBAS CMV

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 11, 2022

COBAS Ammonia/Ethanol/CO2 Control Normal Roche Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 6, 2022

CA2 Calcium Gen.2 Cobas Integra / cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 31, 2022

TDM Control Set Roche Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 31, 2022

COBAS Ammonia/Ethanol/CO2 Calibrator Roche Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 31, 2022

ACCU-CHEK Instant Control

Manufacturer:

BIONOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 31, 2022

COBAS Eco-D Eco Tergent Cobas C 311 Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 30, 2022

COBAS Cleaner COBAS INTEGRA COBAS C 111

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 30, 2022

COBAS cfDNA Sample Preparation Kit (cfDNA SP)

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 22, 2022

VENTANA pan-TRK (EPR17341) Assay

Manufacturer:

VENTANA MEDICAL SYSTEMS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 14, 2022

COBAS T-Uptake Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 21, 2022

COBAS Calcitonin CalSet Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 31, 2022

CALSET Folate cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 20, 2022

PreciControl Vitamin D total III cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 11, 2022

COBAS Digitoxin CalSet Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 6, 2022

COBAS Elecsys Vitamin D total III cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 29, 2021

CalSet HCG STAT and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 29, 2021

COBAS CalSet Vitamin D total III cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 29, 2021

Cobas CT/NG Qualitative nucleic acid test

Manufacturer:

ROCHE MOLECULAR SYSTEMS INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 15, 2021

COBAS PCR Urine Sample Kit

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 10, 2021

HEMOLYZING Reagent Roche/ Hitachi

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 7, 2021

COBAS A1C-3 cobas c111 Tina-quant Hemoglobin A1c Gen.3

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 5, 2021

COBAS HDLC4 cobas c 111 HDL-Cholesterol Gen.4

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 5, 2021

COBAS Fe Standard Roche Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 5, 2021

COBAS HDLC4 HDL-Cholesterol Gen.4 COBAS INTEGRA/ cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 5, 2021

COBAS TP2 Total Protein Gen.2 COBAS INTEGRA / cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 5, 2021

COBAS CMV IgM Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 5, 2021

ACCU-CHEK Instant Test Strips

Manufacturer:

ROCHE DIABETES CARE, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 29, 2021

ACCU-CHEK Guide Control

Manufacturer:

BIONOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 25, 2021

COBAS HPV Qualitative nucleic acid test for use on the cobas 6800/8800 systems

Manufacturer:

ROCHE MOLECULAR SYSTEMS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 25, 2021

ProCell II M cobas e 801

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 19, 2021

ACCU-CHEK Instant Linearity Test Kit

Manufacturer:

BIONOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 15, 2021

ACCU-CHECK Guide Test Strips

Manufacturer:

ROCHE DIABETES CARE, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 15, 2021

COBAS SCC Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICSGMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 11, 2021

COBAS FSH CalSet II Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 11, 2021

ELECSYSβ-CrossLaps/Serum cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 2, 2021

COBAS Elecsys FT3 III cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 2, 2021

Elecsys Calcitonin cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 29, 2021

COBAS PreciControl Vitamin D total II Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 23, 2021

COBAS CalSet Myoglobin cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 23, 2021

COBAS CK-MB CalSet Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 22, 2021

COBAS Elecsys CK-MB Elecsys and cobas e analyzer

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 22, 2021

COBAS Vitamin D Total II CalSet Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 18, 2021

COBAS Elecsys Troponin I cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 17, 2021

COBAS Elecsys Myoglobin cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 15, 2021

COBAS Elecsys Anti-HAV cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 11, 2021

COBAS Diluent Universal cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 11, 2021

COBAS Elecsys hGH cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 25, 2021

COBAS Elecsys Anti-HCV II cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 25, 2021

COBAS Diluent MultiAssay cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 25, 2021

PRECLEAN II M cobas e 801

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 25, 2021

Free βhCG Calset Elecsys and cobas e analzyers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 15, 2021

PreciControl SARS-CoV-2 Antigen cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 8, 2021

COBAS 8000 e 801 Module and Accessories

Manufacturer:

HITACHI HIGH-TECHNOLOGIES CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 6, 2021

COBAS Elecsys Rubella IgG cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 27, 2021

COBAS Elecsys HE4 cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 21, 2021

COBAS Elecsys CMV IgM cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 21, 2021

COBAS Elecsys CMV IgG Avidity cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 19, 2021

COBAS Elecsys CK-MB cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 19, 2021

COBAS Elecsys Syphilis cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 18, 2021

COBAS Elecsys CMV IgG cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 14, 2021

COBAS Elecsys Sirolimus cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 12, 2021

COBAS Elecsys Toxo IgG cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 12, 2021

COBAS Elecsys CYFRA 21-1 cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 10, 2021

COBAS Elecsys Everolimus cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 10, 2021

COBAS Elecsys Vitamin D Total II cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 10, 2021

COBAS Elecsys Tacrolimus cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 10, 2021

COBAS Elecsys Anti-TPO cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 7, 2021

COBAS SCC CalSet Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 7, 2021

COBAS Elecsys ACTH cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 6, 2021

Elecsys Anti-CCP cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 6, 2021

COBAS Elecsys Folate III cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 5, 2021

COBAS Elecsys Calcitonin cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 4, 2021

COBAS Elecsys N-MID Osteocalcin cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 4, 2021

COBAS HIV-1 Quantitative Nucleic Acid Test for Use on The cobas 4800 System (c4800 HIV-1 AMP/ DET)

Manufacturer:

ROCHE MOLECULAR SYSTEMS.,INC

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 4, 2021

COBAS Elecsys Cyclosporine cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 3, 2021

COBAS Elecsys IgE II cobas and analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 28, 2021

COBAS HBV Quantitative Nucleic Acid Test for Use on The Cobas 4800 System

Manufacturer:

ROCHE MOLECULAR SYSTEMS INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 27, 2021

COBAS Elecsys FT3 III cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 19, 2021

COBAS Elecsys Vitamin B12 II cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 16, 2021

COBAS Elecsys Tg II cobas and analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 15, 2021

COBAS Elecsys Cortisol II cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 15, 2021

COBAS Elecsys Anti-HAV IgM cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 15, 2021

COBAS SARS-CoV-2 Qualitative nucleic acid test for use on the cobas 6800/8800 systems

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 12, 2021

COBAS Elecsys CA 72-4 cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 12, 2021

COBAS Elecsys Insulin Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 10, 2021

COBAS Elecsys LH cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 10, 2021

COBAS HCV Quantitative Nucleic Acid Test For Use On The Cobas 4800 System (c4800 HCV AMP/ DET)

Manufacturer:

ROCHE MOLECULAR SYSTEMS,INC

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 9, 2021

COBAS Elecsys DHEA-S cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 6, 2021

COBAS Elecsys C-Peptide cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 6, 2021

COBAS Elecsys Anti-Tg cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 2, 2021

COBAS h 232 and Accessories

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 24, 2021

COBAS HCV GT HCV genotyping test for use on the cobas 4800 System (c4800 HCV GT AMP/ DET)

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 24, 2021

COBAS 4800 System Specimen Diluent 2 (c4800 SD 2)

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 23, 2021

COBAS HCV GT Control Kit For Use On The Cobas 4800 System (c4800 HCV GT CTLS)

Manufacturer:

ROCHE MOLECULAR SYSTEMS,INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 23, 2021

COBAS Elecsys total P1NP cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 22, 2021

COBAS 4800 System Lysis Kit 2

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 22, 2021

COBAS HBV/HCV/HIV-1 Control Kit (c4800 HBV/HCV/HIV CTLS)

Manufacturer:

ROCHE MOLECULAR SYSTEMS,INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 22, 2021

COBAS EGFR Mutation Test v2 (EGFR V2)

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 21, 2021

COBAS Elecsys Prolactin II cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 20, 2021

COBAS Elecsys PTH cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 20, 2021

COBAS Elecsys SHBG cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 20, 2021

COBAS Elecsys CA 19-9 cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 17, 2021

COBAS 6000 e 601 and Accessories

Manufacturer:

HITACHI HIGH-TECHNOLOGIES CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 17, 2021

COBAS Elecsys T4 cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 17, 2021

COBAS Elecsys AFP cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 17, 2021

COBAS Elecsys Ferritin cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 17, 2021

COBAS Elecsys CEA cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 17, 2021

COBAS PreciControl Lung Cancer Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 16, 2021

COBAS Elecsys FSH cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 16, 2021

COBAS Elecsys Estradiol III cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 16, 2021

COBAS Elecsys NSE cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 16, 2021

COBAS Elecsys T3 cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 16, 2021

COBAS Elecsys Anti-HBc II Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 16, 2021

COBAS Elecsys β-CrossLaps/serum cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 16, 2021

COBAS Elecsys Testosterone II cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 16, 2021

COBAS PreciControl Anti-HBc II Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 10, 2021

COBAS GENT2 ONLINE TDM Gentamicin cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 10, 2021

SD BIOSENSOR SARS-CoV-2 Rapid Antibody Test

Manufacturer:

SD BIOSENSOR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 3, 2021

COBAS GLDH3 GLDH Gen.3 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 29, 2021

COBAS 4800 CT / NG Controls Kit

Manufacturer:

ROCHE MOLECULAR SYSTEMS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 24, 2021

COBAS 4800 CT / NG Amplification/Detection Kit

Manufacturer:

ROCHE MOLECULAR SYSTEMS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 24, 2021

COBAS 4800 System Control Diluent Kit

Manufacturer:

ROCHE MOLECULAR SYSTEMS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 24, 2021

COBAS ASTP2 Aspartate Aminotransferase acc. to IFCC II cobas systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 6, 2021

COBAS ALTP2 Alanine Aminotransferase acc. to IFCC II cobas systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 6, 2021

COBAS Ampliprep/COBAS TaqMan HIV-1 Qualitative Tes, v2.0 (HI2QCAP)

Manufacturer:

ROCHE MOLECULAR SYSTEM INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 19, 2021

PreciControl HCC Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 9, 2021

COBAS Elecsys GDF-15 cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 30, 2021

COBAS CalSet PIVKA-II Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 17, 2021

Elecsys Tg II cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 17, 2021

COBAS e 411 Analyzer (Rack System) and Accessories

Manufacturer:

HITACHI HIGH-TECHNOLOGIES CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 13, 2021

COBAS Tg II CalSet cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 9, 2021

Elecsys T4 cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 9, 2021

COBAS Elecsys T3 cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 9, 2021

MAGNA Pure 96 DNA Tissue Lysis Buffer

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 8, 2021

Elecsys PIVKA-II Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 3, 2021

COBAS CKMB Creatine Kinase-MB cobas c111

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 26, 2021

HAPT2 Tina-quant Haptoglobin ver.2 Cobas Integra / cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 26, 2021

MagNA Pure 96 External Lysis Buffer

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 25, 2021

MagNA Pure 96 Bacterial Lysis Buffer

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 22, 2021

COBAS CK Creatine Kinase COBAS INTEGRA / cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 22, 2021

COBAS CK Creatine Kinase cobas c 111

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 19, 2021

Li+ Electrode COBAS INTEGRA ISE Modules

Manufacturer:

ROCHE DIAGNOSTICS INTL, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 18, 2021

COBAS CKMB Creatine Kinase-MB COBAS INTEGRA/cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 18, 2021

COBAS CRP4 Tina-quant C-Reactive Protein IV cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 11, 2021

MagNA Pure 96 Instrument and Accessories

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 8, 2021

COBAS SARS-CoV-2 Control Kit Positive control kit for use on the cobas 6800/8800 Systems

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 5, 2021

COBAS LACT2 Lactate Gen.2 Cobas Integra / cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2021

VENTANA UltraView Red ISH DIG Detection Kit

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 28, 2021

VENTANA UltraView SISH DNP Detection Kit

Manufacturer:

VENTANA MEDICAL SYTEMS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 28, 2021

VENTANA anti-HER2/neu (4B5) Rabbit Monoclonal Prim

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 28, 2021

COBAS HCV Quantitative nucleic acid test for use on the cobas 6800/8800 systems

Manufacturer:

ROCHE MOLECULAR SYSTEMS INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 27, 2021

COBAS Elecsys Anti-HBc IgM Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.,

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 27, 2021

VENTANA INFORM HER 2 Dual ISH DNA Probe Cocktail

Manufacturer:

VENTANA MEDICAL SYSTEMS SYSTEMS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 25, 2021

MagNA Pure 96 DNA and Viral NA Small Volume Kit

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 25, 2021

MagNA Pure 96 DNA and Viral NA Large Volume Kit

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 25, 2021

COBAS Preciset TDM I Roche Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 20, 2021

ELECSYS Anti-CCP Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 20, 2021

COBAS PAPP-A CalSet Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 20, 2021

COBAS Precipath Fructosamine Roche Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 20, 2021

COBAS Precinorm Fructosamine Roche Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 20, 2021

COBAS Precimat Fructosamine Roche Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 20, 2021

COBAS C.f.a.s. Cystatin C Roche Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 19, 2021

COBAS ECO-D Roche/Hitachi Cobas c 501/502 Analyzer

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 19, 2021

COBAS AFP Calset II Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 19, 2021

ELECYS Insulin Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 19, 2021

COBAS Folate III CalSet Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 19, 2021

COBAS Total P1NP Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 19, 2021

COBAS APOAT Tina-quant Apolipoprotein A-1 ver.2 Cobas Integra / cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 19, 2021

COBAS ISE Diluent Gen.2 Roche/Hitachi

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 19, 2021

COBAS APOBT Tina-quant Apolipoprotein B ver.2 Cobas Integra / cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 19, 2021

COBAS SCCS (Special Cell Cleaning Solution) cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 16, 2021

COBAS PreciControl Anti-CCP Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 16, 2021

COBAS ISE Deproteinizer Cobas c 111

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 16, 2021

COBAS Elecsys T3 Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 15, 2021

COBAS C-Peptide CalSet Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 15, 2021

COBAS A1C-3 Tina-quant [a] Hemoglobin A1c Gen.3 Cobas Integra / Cobas c Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 15, 2021

ELECSYS Testosterone II Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 15, 2021

COBAS NACL Diluent NaCI 9% cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 13, 2021

COBAS HIV Combi PT Elecsys and Cobas e Analyzer

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 11, 2021

COBAS ASTL Aspartate Aminotransferase Cobas Integra / cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 4, 2021

COBAS Elecsys AMH Plus cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 4, 2021

COBAS CRPHS cobas c 111 Cardiac C-Reactive Protein (Latex) High Sensitive

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 4, 2021

COBAS T4 Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 30, 2020

COBAS INTEGRA 400 Plus and Accessories

Manufacturer:

ROCHE DIAGNOSTICS INTL., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 30, 2020

COBAS HCG+β CalSet Elecsys and Cobas e Analyzer

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 30, 2020

COBAS ISE Internal Standard Gen.2 Roche/Hitachi

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 30, 2020

COBAS Elecsys HBsAg Confirmatory Test Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 28, 2020

COBAS Elecsys Ferritin Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 28, 2020

CO2-L Bicarbonate Liquid COBAS INTEGRA/cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 26, 2020

COBAS PreciControl Anti-HBs Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 26, 2020

COBAS CERU Ceruloplasmin COBAS INTEGRA / cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 26, 2020

COBAS PreciControl Anti-HBc IgM Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 26, 2020

COBAS GLUC2 Glucose HK Cobas Integra cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 21, 2020

COBAS N-MID Osteocalcin CalSet cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 18, 2020

COBAS PREA Prealbumin Cobas Integra / cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 17, 2020

COBAS ISE Cleaning Solution / Elecsys SysClean Roche Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 15, 2020

COBAS C3C-2 Tina-quant Complement C3c ver.2 Cobas Integra / cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 11, 2020

COBAS Precipath PUC Roche Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 11, 2020

COBAS Elecsys C-Peptide Elecsys and Cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 11, 2020

COBAS Hemolyzing Reagent Gen.2 Cobas Integra

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 11, 2020

COBAS LIPC Lipase Colorimetric COBAS INTEGRA / Cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 10, 2020

C.f.a.s. Proteins Calibrator for Automated Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 10, 2020

COBAS C4-2 Tina-quant Complement C4 ver.2 Cobas Integra/cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 10, 2020

COBAS Diluent MultiAssay Elecsys and Cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 7, 2020

Preciset RF Roche / Hitachi

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 4, 2020

COBAS Elecsys AFP Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 3, 2020

COBAS PRECINORM PUC Roche Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 1, 2020

NaCl Diluent 9% Cobas Integra

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 1, 2020

COBAS Precipath Protein Roche Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 1, 2020

COBAS GGT-2 y-Glutamyl-transferase ver.2 COBAS INTEGRA / cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 1, 2020

COBAS Elecsys CEA Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 1, 2020

COBAS C.f.a.s. Lipids Calibrator For Automated Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 1, 2020

C.f.a.s. CK-MB Calibrator for automated systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 29, 2020

TRIGL Triglycerides COBAS INTEGRA / cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 29, 2020

COBAS Elecsys SHBG Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 29, 2020

COBAS SHBG CalSet Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 26, 2020

COBAS Total P1NP CalSet Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 26, 2020

COBAS CHOL2 Cholesterol Gen.2 COBAS INTEGRA / Cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 26, 2020

COBAS PreciControl Anti-HCV Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 22, 2020

COBAS Sirolimus CalSet Elecsys and cobas e analyze

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 22, 2020

COBAS Everolimus CalSet Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 22, 2020

COBAS UA2 Uric Acid ver.2 Cobas Integra / cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 22, 2020

COBAS hGH Calset Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 22, 2020

COBAS C.f.a.s PUC Roche Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 20, 2020

COBAS PreciControl Everolimus Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 20, 2020

COBAS Elecsys Sirolimus Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 20, 2020

COBAS Everolimus Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 17, 2020

PROBEWASH M Modular Analytics E170, cobas e 601 and cobas e 602 analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 16, 2020

Elecsys CYFRA 21-1 Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 16, 2020

COBAS CYFRA 21-1 CalSet Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 16, 2020

COBAS Diluent Universal 2 Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 12, 2020

COBAS Elecsys LH Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 11, 2020

COBAS PHOS2 Phosphate (Inorganic) ver.2 Cobas Integra / cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 10, 2020

NH3L Ammonia COBAS INTEGRA / cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 10, 2020

COBAS Anti HCV II Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 10, 2020

NSE CalSet Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 6, 2020

COBAS LH CalSet II Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 6, 2020

COBAS T-Uptake CalSet Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 6, 2020

COBAS Elecsys Vitamin B12 II Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 6, 2020

COBAS Vitamin B12 II CalSet Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 4, 2020

COBAS T4 CalSet Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 2, 2020

COBAS T3 CalSet Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 2, 2020

COBAS Elecsys FSH Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 2, 2020

PRECICONTROL Tumor Marker Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 29, 2020

COBAS BILD2 cobas c 111 Bilirubin Direct Gen.2

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 26, 2020

COBAS RF Control Set Roche Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 26, 2020

COBAS FRA Fructosamine Cobas Integra / cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 23, 2020

COBAS CEA CalSet Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 23, 2020

COBAS Elecsys Anti-HBS II Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 21, 2020

COBAS RF-II Tina-quant Rheumatoid Factors II COBAS INTEGRA / cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 20, 2020

TRSF2 Tina-quant Transferrin ver.2 COBAS INTEGRA / cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 20, 2020

COBAS STFR Tina-quant Soluble Transferrin Receptor COBAS INTEGRA / cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 19, 2020

COBAS CRPLX C-Reactive Protein (Latex) Cobas Integra/ cobas c system

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 19, 2020

UIBC Unsaturated Iron Binding Capacity COBAS INTEGRA / cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 16, 2020

COBAS h 232 and Accessories

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 13, 2020

COBAS PHNY2 ONLINE TDM Phenytoin cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 13, 2020

COBAS 6800 Systems and Accessories

Manufacturer:

ROCHE DIAGNOSTICS INTERNATIONAL, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 8, 2020

Elecsys Prolactin II Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 7, 2020

Elecsys BRAHMS PCT Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 5, 2020

COAGUCHEK Pro II Coagulation Meter and Accessories

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 1, 2020

COAGUCHEK Pro II Coagulation Meter and Accessories

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 1, 2020

COBAS CKMBL Creatine Kinase-MB Cobas Integra / cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 25, 2020

COBAS ProBNP II CalSet Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 23, 2020

COBAS Elecsys Anti-TSHR Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 22, 2020

ISE Solution 2 COBAS INTEGRA

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 20, 2020

COBAS Precinorm Protein Roche Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 20, 2020

COBAS MYOGLOBIN Control Set Roche Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 20, 2020

ISE Calibrator Indirect / Urine COBAS INTEGRA

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 17, 2020

COBAS ISE Solution 3 Cobas Integra

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 17, 2020

Diluent Hepatitis A Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH., GERMANY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 16, 2020

COBAS ISE Solution 1 Cobas Integra

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 15, 2020

ISE Reference Electrolyte COBAS INTEGRA

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 15, 2020

COBAS ISE Etcher Cobas Integra

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 14, 2020

CLEAN Cleaner Cassette COBAS INTEGRA

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 14, 2020

ROCHE Folate RBC Hemolyzing Reagent Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 14, 2020

ISE Calibrator Direct COBAS INTEGRA

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 14, 2020

COBAS CA 15-3 II CalSet Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 14, 2020

COBAS ISE Deproteinizer Cobas Integra

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 12, 2020

COBAS LIPC cobas c 111 Lipase Colometric Assay

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 9, 2020

COBAS ASTLP Aspartate Aminotransferase PyP cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 9, 2020

AMY-P a-Amylase EPS Pancretic Cobas Integra / cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 9, 2020

Cobas Elecsys hGH Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 9, 2020

COBAS Precicontrol Varia Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 9, 2020

COBAS ALTLP (Alanine Aminotransferase PyP) cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 4, 2020

COBAS A1CD2 Hemolyzing Reagent Gen.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 3, 2020

BILD2 Bilirubin Direct Gen.2 Cobas Integra / cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 2, 2020

COBAS UREAL Urea/Bun Cobas Integra cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 31, 2020

COBAS Elecsys CA 72-4 Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 30, 2020

COBAS Elecsys Anti-Tg Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 28, 2020

COBAS Elecsys Vitamin D total Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 28, 2020

COBAS Diluent Estradiol / Progesterone Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 27, 2020

ELECSYS Anti-HAV Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2020

Elecsys CMV IgG Avidity Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 21, 2020

Cobas b 123 < 3 > POC System

Manufacturer:

ROCHE DIAGNOSTICS INTERNATIONAL LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 19, 2020

COBAS PreciControl Anti-HAV Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 19, 2020

COBAS Elecsys HSV-2 IgG Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 16, 2020

COBAS Vitamin D Total CalSet Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 9, 2020

COBAS PTH CalSet Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 7, 2020

COBAS Elecsys HSV-1 IgG Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 4, 2020

ROCHE Elecsys CMV IgG Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 28, 2020

COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0

Manufacturer:

ROCHE MOLECULAR SYSTEMS INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 24, 2020

COBAS Elecsys β-CrossLaps/Serum Elecsys and cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 24, 2020

COBAS ISE Reference Electrolyte Roche/Hitachi

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 22, 2020

COBAS CKMBL cobas c 111 Creatine Kinase - MB

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 20, 2020

COBAS HIV-1 Quantitative nucleic acid test for use on the COBAS 6800/8800 Systems

Manufacturer:

ROCHE MOLECULAR SYSTEMS INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 14, 2020

Combur 10 Test UX (SG, pH, LEU, NIT, PRO, GLU, KET, UBG, BIL, ERY/Hb, COMP)

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 10, 2020

COBAS ROCHE Accutrend Triglycerides

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 7, 2020

Cobas Accutrend Control G

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 6, 2020

COBAS HBV Quantitative nucleic acid test for use on the cobas 6800/8800 Systems

Manufacturer:

ROCHE MOLECULAR SYSTEMS INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 3, 2020

COBAS AmpliPrep/COBAS TaqMan CMV Test (CMVCAP)

Manufacturer:

ROCHE MOLECULAR SYSTEMS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 2, 2020

COBAS AmpliPrep/COBAS TaqMan HCV Quantitative Test, v2.0 (HCVQTV2)

Manufacturer:

ROCHE MOLECULAR SYSTEMS INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 30, 2020

COBAS NHP Negative Control Kit Normal, non-reactive human plasma control kit for use on the cobas 6800/8800 systems

Manufacturer:

ROCHE MOLECULAR SYSTEMS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 22, 2020

cobas Influenza A/B Quality Control Kit for use on the cobas Liat System

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 18, 2020

cobas Influenza A/B & RSV Quality Control Kit for use on the cobas Liat System

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 14, 2020

COBAS Influenza A/B Nucleic acid test for use on the cobas Liat System

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 9, 2020

COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, V2.0

Manufacturer:

ROCHE MOLECULAR SYSTEMS INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 29, 2020

ACCU-CHEK Guide Wireless Blood Glucose Meter Only

Manufacturer:

SANMINA CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 19, 2020

VENTANA HE 600 Cleaning Solution

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 13, 2020

VENTANA HE 600 Eosin

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 13, 2020

VENTANA HE 600 Hematoxylin

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 13, 2020

VENTANA HE 600 Transfer Fluid

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 13, 2020

VENTANA HE 600 Bluing

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 13, 2020

VENTANA HE 600 Wash

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 4, 2020

COBAS BENZ Abuscreen OnLine Benzodiazepines COBAS INTEGRA

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 2, 2020

VENTANA HE 600 Differentiating Solution

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 1, 2020

VENTANA HE 600 Coverslip Activator

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 28, 2020

VENTANA HE 600 Organic Solution

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 28, 2020

Elecsys AMH Plus Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 21, 2020

COBAS Elecsys proBNP II cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 7, 2020

SMS/Acid Wash Roche / Hitachi

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 2, 2020

COBAS Elecsys BRAHMS PCT cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 24, 2020

COBAS PreciControl Maternal Care Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 19, 2020

COBAS C1 Calibration Solution 1 cobas b 121, Roche OMNI C

Manufacturer:

ROCHE DIAGNOSTICS INTL, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 6, 2020

COBAS C2 Calibration Solution 2 cobas b121, Roche OMNI C

Manufacturer:

ROCHE DIAGNOSTICS INTL, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 21, 2020

ACCU-CHEK Softclix Lancets

Manufacturer:

ROCHE DIABETES CARE GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 21, 2020

ACCU-CHEK Performa and Accessories

Manufacturer:

SANMINA CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 10, 2020

ACCU-CHEK Active Control

Manufacturer:

ROCHE DIABETES CARE GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 10, 2020

COBAS INSTC Instrument Check cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 30, 2019

MDNII ONLINE DAT Methadone II Cobas Integra

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 22, 2019

THC II ONLINE DAT Cannabinoids II Cobas Integra

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 22, 2019

COBAS CRPL3 C-Reactive Protein Gen.3 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 22, 2019

BENZ ONLINE DAT Benzodiazepin Plus cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 22, 2019

COBAS PCP Abuscreen OnLine Phencyclidine Cobas Integra

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 11, 2019

OPI ONLINE DAT Opiates 300/2000 Cobas Integra

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 11, 2019

LDLC3 LDL-Cholesterol Gen.3 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 17, 2019

COBAS PPX Abuscreen Online Propoxyphene Cobas Integra

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 17, 2019

COBAS MTQL ONLINE DAT Methaqualone COBAS INTEGRA

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 17, 2019

ELECSYS Troponin T hs cobas e analyzer

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 7, 2019

ELECSYS Troponin T hs STAT cobas e analyzer

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 7, 2019

COBAS Elecsys Troponin T hs cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 19, 2019

COBAS AmpliPrep/COBAS TaqMan Wash Reagent (PG WR)

Manufacturer:

ROCHE MOLECULAR SYSTEMS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 18, 2019

COMBITROL TS+ Level 2

Manufacturer:

BIONOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 6, 2019

VENTANA iScan Coreo and Accessories

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 2, 2019

COMBITROL TS+ Level 3

Manufacturer:

BIONOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2019

COBAS 8000 c 701 Module and Accessories

Manufacturer:

HITACHI HIGH TECHNOLOGIES CORP.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 19, 2019

COMBITROL TS+ Level 1

Manufacturer:

BIONOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 19, 2019

COBAS 8000 e 602 Module and Accessories

Manufacturer:

HITACHI HIGH TECHNOLOGIES CORP.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 19, 2019

COBAS Elecsys HBsAg II Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 13, 2019

COBAS CO2-L Bicarbonate Liquid cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 9, 2019

COBAS 8000 c 702 Module and Accessories

Manufacturer:

HITACHI HIGH TECHNOLOGIES CORP.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 9, 2019

COBAS 8000 C 502 Module and Accessories

Manufacturer:

HITACHI HIGH TECHNOLOGIES CORP.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2019

ROCHE CKL cobas c 111 Creatine Kinase

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2019

COBAS Multiclean Roche/Hitachi

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 19, 2019

Data sourced from BPOM (Badan Pengawas Obat dan Makanan), Indonesia.

Last updated: December 2025