PT. ROCHE INDONESIA
Indonesia1074 products represented85 manufacturers
VerifiedKemenkes (Ministry of Health) · official registry
1074
Total Products
85
Manufacturers
3
Product Classes
4
Risk Classes
Registered address
- Address
- Gedung AIA Central Lantai 36 Jl. Jend. Sudirman KAV. 48A RT/RW 003/004 Kelurahan Karet Semanggi
Regulatory footprint
Search PT. ROCHE INDONESIA across other regulatory registries
Risk classification breakdown
Distribution of represented products across risk classes
Kelas Resiko : A15514.4% of total
Kelas Resiko : B68263.5% of total
Kelas Resiko : C20018.6% of total
Kelas Resiko : D373.4% of total
Manufacturer portfolio
Products organized by manufacturer
ROCHE DIAGNOSTICS GMBH.
Germany
635 Products
ROCHE DIAGNOSTICS GMBH
Germany
71 Products
VENTANA MEDICAL SYSTEMS, INC.
United States
57 Products
VENTANA MEDICAL SYSTEMS INC.
United States
39 Products
ROCHE MOLECULAR SYSTEMS, INC.
United States
37 Products
ROCHE MOLECULAR SYSTEMS INC.
United States
23 Products
ROCHE DIAGNOSTICS (SUZHOU) LTD
China
18 Products
BIONOSTICS INC.
United States
13 Products
ROCHE DIAGNOSTICS INTL, LTD.
Switzerland
12 Products
ROCHE DIAGNOSTICS (SUZHOU) LTD.
China
11 Products
ROCHE MOLECULAR SYSTEM, INC., USA
United States
8 Products
ROCHE MOLECULAR SYSTEMS
United States
7 Products
HITACHI HIGH TECHNOLOGIES CORP.
Japan
7 Products
ROCHE DIAGNOSTICS INTERNATIONAL LTD.
Switzerland
6 Products
ROCHE DIAGNOSTICS INTERNATIONAL LTD
Switzerland
6 Products
ROCHE MOLECULAR SYSTEM, INC.
United States
6 Products
ROCHE DIAGNOSTICS, LTD.
Germany
5 Products
ROCHE DIABETES CARE GMBH.
Germany
5 Products
HTL-STREFA S.A
Poland
4 Products
ROCHE DIABETES CARE, INC.
United States
4 Products
ROCHE DIAGNOSTICS AUTOMATION SOLUTIONS GMBH
Germany
4 Products
HITACHI HIGH-TECHNOLOGIES CORPORATION.
Japan
4 Products
ROCHE DIAGNOSTICS INTERNATIONAL, LTD.
Switzerland
3 Products
77 ELECTRONICS INSTRUMENT INDUSTRY LTD.
Hungary
3 Products
ROCHE MOLECULAR SYSTEMS, INC
United States
3 Products
ROCHE DIAGNOSTICS GMBH.,
Germany
3 Products
VENTANA MEDICAL SYSTEMS INC
United States
3 Products
VENTANA MEDICAL SYSTEMS.
United States
3 Products
ROCHE MOLECULAR SYSTEMS,INC
United States
3 Products
ROCHE DIAGNOSTICS AUTOMATION SOLUTION GMBH
Germany
2 Products
HITACHI HIGH-TECHNOLOGIES CORPORATION
Japan
2 Products
ROCHE DIAGNOSTICS INTERNATIONAL, LTD
Switzerland
2 Products
SANMINA SCI INDIA PVT LTD
India
2 Products
ALTEK MEDICAL (KUNSHAN) LIMITED
China
2 Products
EVER PHARMA JENA GMBH
Germany
2 Products
SANMINA CORPORATION
United States
2 Products
SANMINA-SCI INDIA PVT LTD
India
2 Products
ROCHE DIAGNOSTIC GMBH
Germany
2 Products
VENTANA MEDICAL SYSTEMS, INC
United States
2 Products
PANASONIC HEALTHCARE CO., LTD.
Japan
2 Products
ROCHE DIAGNOSTICS GmbH.
Germany
2 Products
DIAZYME LABORATORIES.
United States
2 Products
SD BIOSENSOR
Korea
2 Products
TERMO FISHER SCIENTIFIC (SUZHOU) INSTRUMENTS CO., LTD.
China
2 Products
LRE MEDICAL GMBH.
Germany
1 Products
HAMILTON BONADUZ AG.
Switzerland
1 Products
ROCHE DIAGNOSTICS INTL LTD.
Switzerland
1 Products
HITACHI HIGH-TECH CORPORATION
Japan
1 Products
CLINIQA CORPORATION
United States
1 Products
BIONOSTICS INC
United States
1 Products
ASAHI POLYSLIDER COMPANY LIMITED
Japan
1 Products
HITACHI HIGH-TECH CORPORATION NAKA DIVISION
Japan
1 Products
FISHER DIAGNOSTICS.
United States
1 Products
SANMINA-SCI (SHENZHEN) LTD.
China
1 Products
FFEI LTD.
United Kingdom
1 Products
CARL ZEISS CMP GMBH
Germany
1 Products
ROCHE MOLECULAR SYSTEMS.INC.
United States
1 Products
ALTEK MEDICAL (KUNSHAN) LTD.
China
1 Products
ROCHE DIABETES CARE., INC.
United States
1 Products
VENTANA MEDICAL SYSTEM INC
United States
1 Products
VENTANA MEDICAL SYSTEMS INC., USA
United States
1 Products
ROCHE DIAGNOSTICS GMH.
Germany
1 Products
GERRESHEIMER REGENSBURG, GMBH
Germany
1 Products
ROCHE DIAGNOSTICS GMBH. CENTRALISED AND POINT OF CARE SOLUTIONS
Germany
1 Products
VENTANA MEDICAL SYSTEMS INC.,
United States
1 Products
WEIDMANN MEDICAL TECHNOLOGY AG
Switzerland
1 Products
Ventana Medical Systems Inc.
United States
1 Products
HITACHI HIGH TECHNOLOGIES CORPORATION.
Japan
1 Products
VENTANA MEDICAL SYSTEM INC.
United States
1 Products
BALDA MEDICAL GMBH
Germany
1 Products
PHC CORPORATION
Japan
1 Products
CANTERBURY SCIENTIFIC LTD.
New Zealand
1 Products
BIONOSTICS, INC.
United States
1 Products
TERMO FISHER SCIENTIFIC INC.
United States
1 Products
ROCHE MOLECULAR SYSTEMS INC
United States
1 Products
ROCHE DIAGNOSTICS INTERNATIONAL LTD.,
Switzerland
1 Products
ROCHE MOLECULAR SYSTEMS INC.,
United States
1 Products
ROCHE DIAGNOSTICSGMBH.
Germany
1 Products
ROCHE MOLECULAR SYSTEMS.,INC
United States
1 Products
ROCHE MOLECULAR SYSTEM INC.
United States
1 Products
VENTANA MEDICAL SYTEMS INC.
United States
1 Products
VENTANA MEDICAL SYSTEMS SYSTEMS INC.
United States
1 Products
ROCHE DIAGNOSTICS INTL., LTD.
Switzerland
1 Products
ROCHE DIAGNOSTICS GMBH., GERMANY
Germany
1 Products
SANMINA CORPORATION.
United States
1 Products
All represented products (1074)
Complete portfolio registered with Ministry of Health
COBAS PreciControl CMV IgG Avidity Elecsys and cobas e analyzers
Feb 11, 2025
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS MPXV
Feb 11, 2025
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CREP2 Creatinine Plus ver.2 COBAS INTEGRA / cobas c systems
Feb 10, 2025
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COAGUCHEK PT Test
Feb 6, 2025
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS S2 Fluid Pack
Feb 6, 2025
- Manufacturer
- ROCHE DIAGNOSTICS INTERNATIONAL, LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ROCHE Cardiac POC Troponin T 2-Level Control
Feb 4, 2025
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys CA 15-3 ll Elecsys and cobas e analyzer
Jan 26, 2025
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS u 601 Urine Analyzer and Accessories
Jan 24, 2025
- Manufacturer
- 77 ELECTRONICS INSTRUMENT INDUSTRY LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ISE Reference Electrolyte Roche / Hitachi cobas c
Jan 23, 2025
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS CA 19-9 Calset Elecsys and cobas e analyzers
Jan 23, 2025
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Insulin CalSet Elecsys and cobas e analyzers
Jan 23, 2025
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS NSE Elecsys and Cobas e Analyzer
Jan 23, 2025
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Elecsys Anti-HAV IgM Elecsys and cobas e analyzers
Jan 22, 2025
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Anti-TPO Elecsys and cobas e analyzers
Jan 20, 2025
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS C.f.a.s. Myoglobin Calibrator for automated systems
Jan 20, 2025
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS u 701 Microscopy Analyzer and Accessories
Jan 17, 2025
- Manufacturer
- 77 ELECTRONICS INSTRUMENT INDUSTRY LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys HBeAg Elecsys and Cobas e Analyzers
Jan 13, 2025
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
COBAS p 512 Pre Analytical System and Accessories
Jan 8, 2025
- Manufacturer
- ROCHE DIAGNOSTICS AUTOMATION SOLUTION GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ELECSYS proBNP II cobas e analyzers
Jan 3, 2025
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ACCUTREND Plus
Jan 2, 2025
- Manufacturer
- LRE MEDICAL GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Elecsys HCG+ß cobas e analyzers
Dec 30, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys CA 15-3 II cobas e analyzers
Dec 27, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Elecsys CA 125 II cobas and analyzers
Dec 27, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS LDHI2 (Lactate Dehydrogenase acc. IFCC ver.2
Dec 27, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ACCUTREND Control CH1
Dec 26, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ELECSYS Troponin T hs cobas e analyzers
Dec 24, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys PTH
Dec 24, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Progesterone III cobas e analyzers
Dec 23, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
MICRAL-TEST Microalbuminurie
Dec 23, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS DHEA-S Elecsys and Cobas e Analyzer
Dec 23, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COAGUCHEK aPTT Controls
Dec 23, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Elecsys FSH cobas e analyzers
Dec 23, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Deproteinizer
Dec 23, 2024
- Manufacturer
- ROCHE DIAGNOSTICS INTERNATIONAL, LTD.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
ROCHE CARDIAC Myoglobin cobas h 232
Dec 23, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Control-Test M
Dec 23, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ACCUTREND Control TG1
Dec 19, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS LI (Lithium) cobas c systems
Dec 19, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COAGUCHEK PT Controls
Dec 19, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS ISE Diluent Gen.2 cobas c systems
Dec 17, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Elecsys CA 72-4 cobas e analyzers
Dec 17, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS PreciControl Anti-HBe Elecsys and cobas e analyzers
Dec 17, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ROCHE CARDIAC Control proBNP cobas h 232
Dec 17, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PreciControl HBeAg Elecsys and Cobas e Analy
Dec 16, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS β -CrossLaps CalSet Elecsys and cobas e analyzers
Dec 13, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ELECSYS GAAD
Dec 13, 2024
- Manufacturer
- ROCHE DIAGNOSTICS INTERNATIONAL LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS DNA Sample Preparation Kit (DNA SP)
Dec 13, 2024
- Manufacturer
- ROCHE MOLECULAR SYSTEMS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Preciset DAT Plus II
Dec 13, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS BM-Control-Lactate
Dec 13, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PreciControl Anti-HAV IgM Elecsys and cobas e analyzers
Dec 12, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
cobas Liat Analyzer and Accessories
Dec 12, 2024
- Manufacturer
- ROCHE DIAGNOSTICS INTERNATIONAL LTD
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS 4800 BRAF V600 Mutation Test
Dec 12, 2024
- Manufacturer
- ROCHE MOLECULAR SYSTEMS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
ELECSYS HCG+β
Dec 6, 2024
- Manufacturer
- ROCHE DIAGNOSTICS (SUZHOU) LTD
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CHED2 Cholinesterase/Dibucaine Gen.2 COBAS INTEGRA / cobas c systems
Dec 4, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
ELECSYS HIV Duo cobas e analyzers
Dec 3, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
COBAS ISE Internal Standard Gen.2 cobas c systems
Dec 2, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Pro ISE Analytical Unit and Accessories
Dec 2, 2024
- Manufacturer
- HITACHI HIGH-TECHNOLOGIES CORPORATION
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System
Dec 2, 2024
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
PreciControl Anti-SARS-CoV-2 cobas e analyzers
Dec 2, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS KRAS Mutation Test
Dec 2, 2024
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ROCHE Elecsys HE4 Elecsys and cobas e analyzers
Nov 28, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS x 480 and Accessories
Nov 28, 2024
- Manufacturer
- HAMILTON BONADUZ AG.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS ISE Reference Electrolyte Roche/Hitachi
Nov 28, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Cdiff Nucleic acid test for use on the cobas Liat System
Nov 28, 2024
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Strep A Nucleic acid test for use on the cobas Liat System
Nov 28, 2024
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Strep A Quality Control Kit for use on the cobas Liat System
Nov 26, 2024
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS DHEA-S Calset Elecsys and Cobas e Analyzer
Nov 26, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS® Pulse and Accessories
Nov 22, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
ACCU-FINE Pen Needles
Nov 15, 2024
- Manufacturer
- HTL-STREFA S.A
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA Bluing Reagent
Nov 9, 2024
- Manufacturer
- ROCHE DIAGNOSTICS (SUZHOU) LTD
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS ALTL Alanine Aminotransferase COBAS INTEGRA / cobas c systems
Nov 6, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS THC2 ONLINE DAT Cannabinoids II cobas c systems
Nov 6, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Anti-Tg CalSet Elecsys and cobas e analyzers
Nov 6, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Cleaning Solution
Nov 6, 2024
- Manufacturer
- ROCHE DIAGNOSTICS INTL, LTD.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS omni MGP Reagent
Nov 1, 2024
- Manufacturer
- ROCHE MOLECULAR SYSTEMS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
9180 Electrolyte Analyzer and Accessories
Nov 1, 2024
- Manufacturer
- ROCHE DIAGNOSTICS INTERNATIONAL, LTD
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ELECSYS N-MID Osteocalcin Elecsys and Cobas e Analyzers
Nov 1, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS b 221 System and Accessories
Nov 1, 2024
- Manufacturer
- ROCHE DIAGNOSTICS INTL LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PHOS2 cobas c 111 Phosphate ver.2
Nov 1, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS MPX
Oct 30, 2024
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
COBAS LDHI2 cobas c111 Lactate Dehydrogenase acc. to IFCC ver.2
Oct 28, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS IgE CalSet Elecsys and Cobas e Analyzers
Oct 25, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Diluent NSE Elecsys and cobas e analyzers
Oct 25, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PreciControl Cardiac II Elecsys and Cobas e Analyzers
Oct 25, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PTH Elecsys and Cobas e Analyzers
Oct 25, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PreciControl HE4 Elecsys and cobas e Analyzers
Oct 21, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS HE4 CalSet Elecsys and cobas e Analyzers
Oct 21, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Anti-TPO CalSet Elecsys and cobas e analyzers
Oct 21, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys CA 19-9 Elecsys and cobas e analyzers
Oct 18, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS THEO2 ONLINE TDM Theophylline cobas c systems
Oct 18, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS ALBT2 Tina-quant Albumin Gen.2 Cobas Integra/ cobas c systems
Oct 16, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS AMY-P cobas c 111 α -Amylase EPS Pancreatic
Oct 16, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA HybReady Solution
Oct 14, 2024
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA HER2 Dual ISH 3-in-1 Xenograft Slides
Oct 14, 2024
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS A1CD2 cobas c 111 Hemolyzing Reagent Gen.2
Oct 14, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Anti-HBe Elecsys and cobas e analyzers
Oct 14, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Control Set β2-Microglobulin Roche systems
Oct 11, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Calibrator β-Microglobulin Roche Systems
Oct 11, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS TPUC3 Total Protein Urine/CSF Gen.3 COBAS INTEGRA/ cobas c systems
Oct 11, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Cobas® GLU Linearity Kit
Oct 9, 2024
- Manufacturer
- BIONOSTICS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ROCHE CARDIAC D-Dimer cobas h 232
Oct 8, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS IGA-2 Tina-quant IgA Gen.2 cobas c systems
Oct 8, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
IGG-2 Tina-quant IgG Gen.2 cobas c systems
Oct 7, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Progesterone III Elecsys and cobas e analyzers
Oct 7, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS S1 Rinse Solution cobas b 221, Roche OMNI S
Oct 7, 2024
- Manufacturer
- ROCHE DIAGNOSTICS INTL, LTD.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
PATHWAY HER-2 4 in 1 Control Slides
Oct 7, 2024
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
ROCHE CARDIAC CK-MB cobas h 232
Oct 7, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS ELECSYS Anti-HBs II cobas e 801 analyzers
Oct 4, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
COBAS e 402 Analytical Unit and Accessories
Oct 2, 2024
- Manufacturer
- HITACHI HIGH-TECH CORPORATION
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Anti-HBS II cobas e analyzers
Oct 2, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
COBAS ASLOT Tina-quant Antisterptolysin O cobas c
Oct 1, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
ELECSYS HBsAg II cobas e analyzers
Oct 1, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
COBAS p 612 Pre Analytical System and Accessories
Oct 1, 2024
- Manufacturer
- ROCHE DIAGNOSTICS AUTOMATION SOLUTION GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys HBsAg II quant II cobas e analyzers
Sep 27, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
COBAS CRP Control cobas b 101
Sep 23, 2024
- Manufacturer
- CLINIQA CORPORATION
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ACCU-CHEK Guide Wireless Blood Glucose Meter Only
Sep 17, 2024
- Manufacturer
- SANMINA SCI INDIA PVT LTD
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
ACCU-CHEK Guide Set Wireless Blood Glucose Meter and Lancing Device
Sep 17, 2024
- Manufacturer
- SANMINA SCI INDIA PVT LTD
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COMBITROL Plus B Level 3
Sep 11, 2024
- Manufacturer
- BIONOSTICS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ROCHE/HITACHI Cell Wash Solution I / NAOH-D
Sep 11, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VALP2 ONLINE TDM Valproic Acid cobas c systems
Sep 11, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS SARS-CoV-2 Quality Control Kit for use on the cobas Liat System
Sep 11, 2024
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS HCYS Homocysteine Enzymatic Assay COBAS INTEGRA/ Cobas c Systems
Sep 10, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA PD-L1 (SP263) Assay
Sep 9, 2024
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
Elecsys free βhCG cobas e analyzers
Sep 9, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS SARS-CoV-2 Nucleic acid test for use on the cobas Liat System
Sep 8, 2024
- Manufacturer
- ROCHE MOLECULAR SYSTEMS
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Hb-Calibrator cobas b 221, Roche OMNI S
Sep 4, 2024
- Manufacturer
- ROCHE DIAGNOSTICS INTERNATIONAL, LTD
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS LPA2 Tina-quant Lipoprotein (a) Gen.2 cobas c systems
Sep 4, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
PreciControl AMH Plus Elecsys and cobas e analyzers
Sep 3, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS IGM-2 Tina-quant IgM Gen.2 cobas c systems
Sep 3, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS MYO2 (Tina-quant Myoglobin Gen.2) Cobas Integra / cobas c systems
Aug 30, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PIK3CA Mutation Test (PIK3CA)
Aug 30, 2024
- Manufacturer
- ROCHE MOLECULAR SYSTEMS
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS LPA2 Tina-quant Lipoprotein (a) Gen.2 Cobas c Systems
Aug 28, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS SI2 Serum Index Gen.2 COBAS INTEGRA / cobas c systems
Aug 26, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
VENTANA Basal Cell Cocktail (34βE12+p63)
Aug 22, 2024
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
ACCU-CHEK Active Control
Aug 21, 2024
- Manufacturer
- BIONOSTICS INC
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ACCU-CHEK Softclix Lancets
Aug 19, 2024
- Manufacturer
- HTL-STREFA S.A
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
ACCU-CHEK Safe-T-Pro Uno
Aug 19, 2024
- Manufacturer
- HTL-STREFA S.A
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS Elecsys Anti-HAV II cobas e analyzers
Aug 13, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CREJ2 Cretinine Jaffe Gen.2 cobas c systems
Aug 13, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.,
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS ALP2S ALP IFCC Gen.2 Small cobas c systems
Aug 13, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Cortisol II CalSet Elecsys and cobas e analyzers
Aug 13, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS ACET2 ONLINE TDM Acetaminophen Gen.2 COBAS INTEGRA/ COBAS c sytems
Aug 12, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Progesterone III CalSet Elecsys and cobas e analyzers
Aug 12, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ACCU-CHEK Softclix Lancets
Aug 8, 2024
- Manufacturer
- ASAHI POLYSLIDER COMPANY LIMITED
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
PreciControl Anti-HAV II cobas e analyzers
Aug 8, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CalSet AMH Plus Elecsys and cobas e analyzers
Aug 8, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS c 111 and Accessories
Aug 8, 2024
- Manufacturer
- ROCHE DIAGNOSTICS INTL, LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ROCHE CARDIAC POC Troponin T cobas h 232
Aug 8, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS total PSA CalSet II cobas e analyzers
Aug 4, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
free PSA CalSet cobas e analyzers
Aug 2, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
Accu-Chek Instant S mg/dl Set
Jul 31, 2024
- Manufacturer
- ALTEK MEDICAL (KUNSHAN) LIMITED
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Elecsys Free PSA
Jul 29, 2024
- Manufacturer
- ROCHE DIAGNOSTICS (SUZHOU) LTD
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
ELECSYS Total PSA cobas e analyzers
Jul 11, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
ELECSYS free PSA cobas e analyzers
Jul 11, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
ELECSYS HE4 Elecsys and cobas e analyzers
Jul 9, 2024
- Manufacturer
- ROCHE DIAGNOSTICS (SUZHOU) LTD
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
VENTANA CONFIRM anti-ALK1 (ALK01) Primary Antibody
Jul 3, 2024
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COMBUR 10 Test (SG, pH, LEU, NIT, PRO, GLU, KET, UBG, BIL, ERY/Hb)
Jul 3, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
Elecsys Progesterone III
Jun 28, 2024
- Manufacturer
- ROCHE DIAGNOSTICS (SUZHOU) LTD
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys NSE
Jun 28, 2024
- Manufacturer
- ROCHE DIAGNOSTICS (SUZHOU) LTD
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Elecsys PAPP-A cobas e analyzers
Jun 28, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS proBNP II CalSet cobas e analyzers
Jun 28, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS BARB ONLINE DAT Barbiturate Plus cobas c systems
Jun 20, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS ELECSYS RAW Plus
Jun 19, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ACCU-CHEK Performa Test Strips
Jun 7, 2024
- Manufacturer
- ROCHE DIABETES CARE, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS CYSC2 Tina-quant Cystatin C Gen.2 cobas c systems
Jun 7, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys AMH Plus
Jun 7, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys TSH
Jun 6, 2024
- Manufacturer
- ROCHE DIAGNOSTICS (SUZHOU) LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS FRA Fructosamine cobas c systems
Jun 6, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS™ COC2 ONLINE DAT Cocaine II cobas c systems
Jun 6, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Elecsys Total-Tau CSF
Jun 3, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS p 671 Centrifuge Unit
Jun 3, 2024
- Manufacturer
- ROCHE DIAGNOSTICS AUTOMATION SOLUTIONS GMBH
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS p 671 Centrifuge Unit
May 31, 2024
- Manufacturer
- ROCHE DIAGNOSTICS AUTOMATION SOLUTIONS GMBH
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
B2MG Tina-quant β2-Microglobulin cobas c systems
May 31, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PreciControl Total-Tau
May 29, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
PreciControl Phospho-Tau (181P)
May 27, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS BNZ2 ONLINE DAT Benzodiazepines II cobas c systems
May 27, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ELECSYS Phospho-Tau (181P) CSF
May 27, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ELECSYS Total-Tau CSF
May 27, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS NH3L2 Ammonia II cobas c systems
May 27, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ELECYS Beta-Amyloid (1-42) CSF II
May 21, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
AAT2 Tina-quant α1-Antitrypsin ver.2 cobas c systems
May 21, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ASLOT Tina-quant Antistreptolysin O cobas c systems
May 21, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
THEO2 ONLINE TDM Theophylline cobas c systems
May 21, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS ACETA Acetaminophen COBAS INTEGRA / cobas c systems
May 21, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Elecsys Phospho-Tau (181P) CSF
May 20, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Elecsys Beta-Amyloid (1-42) CSF II
May 20, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA Anti-ERG (EPR3864) Rabbit Monoclonal Primary Antibody
May 20, 2024
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS HBDH2 α-Hydroxybutyrate Dehydrogenase Gen.2 cobas c systems
May 20, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
DIG Digoxin COBAS INTEGRA / cobas c systems
May 20, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS p 471 Centrifuge Unit
May 20, 2024
- Manufacturer
- ROCHE DIAGNOSTICS AUTOMATION SOLUTIONS GMBH
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody
May 16, 2024
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA Anti-P120 Catenin (98) Mouse Monoclonal Primary Antibody
May 14, 2024
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA anti-MSH6 (SP93) Rabbit Monoclonal Primary Antibody
May 13, 2024
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA anti-MLH1 (M1) Mouse Monoclonal Primary Antibody
May 13, 2024
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody
May 13, 2024
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
LI Lithium cobas c systems
May 13, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS AAGP2 Tina-quant α1-Acid Glycoprotein Gen.2 cobas c systems
May 13, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS HCYS Homocysteine Enzymatic Assay cobas c systems
May 9, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ALBT2 Tina-quant Albumin Gen.2 cobas c systems
May 8, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
GLUC2 Glucose HK cobas c systems
May 8, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
SMS Detergent 2 cobas c systems
May 8, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS PreciControl Beta-Amyloid (1-42) II
May 8, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS e 411 Analyzer (Disk System) and Accessories
May 8, 2024
- Manufacturer
- HITACHI HIGH TECHNOLOGIES CORP.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS c 311 and Accessories
May 7, 2024
- Manufacturer
- HITACHI HIGH TECHNOLOGIES CORP.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA Anti-Cytokeratin 17 (SP95) Rabbit Monoclonal Primary Antibody
May 7, 2024
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS 4800 System Wash Buffer Kit
May 7, 2024
- Manufacturer
- ROCHE MOLECULAR SYSTEMS INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS Cell Wash Solution II / Acid Wash
May 7, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA Anti-Epithelial Related Antigen (MOC-31) Mouse Monoclonal Primary Antibody
May 3, 2024
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS 4800 System Liquid Cytology Preparation Kit
May 3, 2024
- Manufacturer
- ROCHE MOLECULAR SYSTEMS INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA Anti-Glypican 3 (GC33) Mouse Monoclonal Primary Antibody
May 3, 2024
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS Control Set DAT I Roche systems
Apr 29, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CERU Ceruloplasmin cobas c systems
Apr 26, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ACCU-CHEK Performance Control
Apr 26, 2024
- Manufacturer
- BIONOSTICS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS THC2 ONLINE DAT Cannabinoids II cobas c systems
Apr 23, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS MPX - 480
Apr 22, 2024
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
COBAS c 303 Analytical Unit and Accessories
Apr 18, 2024
- Manufacturer
- HITACHI HIGH-TECH CORPORATION NAKA DIVISION
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS C4-2 Tina-quant Complement C4 ver.2 cobas c systems
Apr 17, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS® MPX Control Kit
Apr 16, 2024
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS c 503 Analytical Unit and Accessories
Apr 16, 2024
- Manufacturer
- HITACHI HIGH-TECHNOLOGIES CORPORATION
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS SnapPak
Apr 5, 2024
- Manufacturer
- FISHER DIAGNOSTICS.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
BENCHMARK GX and Accessories
Apr 4, 2024
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ACCU-CHECk Active Set and Accessories
Apr 3, 2024
- Manufacturer
- SANMINA-SCI (SHENZHEN) LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COAGUCHEK Softclix Lancet
Mar 28, 2024
- Manufacturer
- HTL-STREFA S.A
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS OPI2 ONLINE DAT Opiates II cobas c systems
Mar 28, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA ROS1 (SP384) Rabbit Monoclonal Primary Antibody
Mar 25, 2024
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS PREA Prealbumin cobas c systems
Mar 25, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA HER2 Dual ISH DNA Probe Cocktail
Mar 25, 2024
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS AMPS2 ONLINE DAT Amphetamines II cobas c systems
Mar 25, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS ISE Standard High
Mar 25, 2024
- Manufacturer
- EVER PHARMA JENA GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Elecsys Folate III
Mar 22, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA DP 200 and Accessories
Mar 22, 2024
- Manufacturer
- FFEI LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
IGA-C Tina-quant IgA CSF cobas c systems
Mar 22, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS HAPT2 Tina-quant Haptoglobin ver.2 cobas c systems
Mar 21, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS UIBC Unsaturated Iron-Binding Capacity cobas c systems
Mar 21, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS ISE Standard Low
Mar 19, 2024
- Manufacturer
- EVER PHARMA JENA GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CalSet B-Amyloid (1-42) II
Mar 19, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CalSet Phospho-Tau (181P)
Mar 19, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS u 411 and Accessories
Mar 18, 2024
- Manufacturer
- ROCHE DIAGNOSTICS INTERNATIONAL LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS 6800 Systems
Mar 18, 2024
- Manufacturer
- ROCHE DIAGNOSTICS INTERNATIONAL LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
ACCU-CHEK Inform II Meter Kit + RF and Accessories
Mar 15, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
CHE2 Cholinesterase Gen.2 cobas c systems
Mar 15, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
LACT2 Lactate Gen.2 cobas c systems
Mar 13, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
BenchMark ULTRA PLUS Instrument
Mar 13, 2024
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS p 471 Centrifuge Unit
Mar 13, 2024
- Manufacturer
- ROCHE DIAGNOSTICS AUTOMATION SOLUTIONS GMBH
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS Elecsys Ferritin
Mar 8, 2024
- Manufacturer
- ROCHE DIAGNOSTICS (SUZHOU) LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA DP 600 slide scanner
Mar 8, 2024
- Manufacturer
- CARL ZEISS CMP GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Elecsys Folate III
Mar 8, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys C-Peptide
Mar 8, 2024
- Manufacturer
- ROCHE DIAGNOSTICS (SUZHOU) LTD
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS e 801 Analytical Unit and Accessories
Mar 7, 2024
- Manufacturer
- HITACHI HIGH-TECHNOLOGIES CORPORATION.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS 5800 System and Accessories
Mar 5, 2024
- Manufacturer
- ROCHE DIAGNOSTICS INTERNATIONAL LTD
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS C3C-2 Tina-quant Complement C3c ver.2 cobas c systems
Mar 5, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS ACP2 Acid Phosphatase Gen.2 cobas c systems
Mar 5, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
DIBU Dibucaine Cobas C Systems
Mar 5, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
OPI 2 ONLINE DAT Opiates II cobas c systems
Mar 1, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS IGM-C Tina-quant IgM CSF cobas c systems
Mar 1, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS ELECSYS CYFRA 21-1
Feb 29, 2024
- Manufacturer
- ROCHE DIAGNOSTICS (SUZHOU) LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS 8000 ISE 900 Module and Accessories
Feb 28, 2024
- Manufacturer
- HITACHI HIGH TECHNOLOGIES CORP.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Calset Folate
Feb 28, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Control Set DAT II Roche systems
Feb 28, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Folate lll Elecsys and cobas e analyzers
Feb 27, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
RF-II Rheumatoid Factors II cobas c systems
Feb 27, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Diluents Universal
Feb 27, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS HIV-1 Nucleic Acid Test for Use on The Cobas 4800 System
Feb 26, 2024
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS 4800 MRSA/SA Controls and Cofactor Kit (c4800 MRSA/SA CTLS/COFR)
Feb 25, 2024
- Manufacturer
- ROCHE MOLECULAR SYSTEMS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ELECSYS HCG+β Elecsys and Cobas e Analyzers
Feb 25, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Folate III Calset
Feb 21, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS 4800 MRSA/SA Amplification/Detection Kit (c4800 MRSA/SA AMP/DET)
Feb 17, 2024
- Manufacturer
- ROCHE MOLECULAR SYSTEMS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys FT4 III cobas e 801 analyzers
Feb 13, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS 4800 Cdiff Amplification/Detection Kit (c4800 CDIFF AMP/DET)
Feb 13, 2024
- Manufacturer
- ROCHE MOLECULAR SYSTEMS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Specimen Pre-Extraction Reagent
Feb 9, 2024
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS Control Set DAT III Roche Systems
Feb 7, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
LDLC3 LDL-Cholesterol Gen.3 cobas c 111
Feb 7, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Anti-TSHR cobas e analyzers
Feb 6, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
LDLC3 LDL-Cholesterol Gen.3 COBAS INTEGRA / cobas
Feb 6, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS 4800 Cdiff Controls and Cofactor Kit (c4800 CDIFF CTLS/COFR)
Feb 6, 2024
- Manufacturer
- ROCHE MOLECULAR SYSTEMS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS 4800 HPV Controls Kit
Feb 2, 2024
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS 4800 HPV Amplification/Detection Kit
Feb 1, 2024
- Manufacturer
- ROCHE MOLECULAR SYSTEMS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
ETOH 2 Ethanol Gen.2 COBAS INTEGRA / cobas c systems
Feb 1, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS 4800 System Sample Preparation Kit
Feb 1, 2024
- Manufacturer
- ROCHE MOLECULAR SYSTEMS.INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS BARB ONLINE DAT Barbiturates Plus cobas c systems
Feb 1, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ACCU-CHEK Instant Set Wireless Blood Glucose Meter and Lancing Device
Jan 27, 2024
- Manufacturer
- ALTEK MEDICAL (KUNSHAN) LIMITED
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
ACCU-CHEK Instant Wireless Blood Glucose Meter Only
Jan 24, 2024
- Manufacturer
- ALTEK MEDICAL (KUNSHAN) LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
SPECIFIES THAT Plus 1 Roche Systems
Jan 22, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Activator Cobas Integra cobas c systems
Jan 18, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ELECSYS Anti-TSHR cobas e analyzers
Jan 18, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CalSet Anti-TSHR cobas and analyzers
Jan 12, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ELECSYS TSH cobas e analyzers
Jan 12, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS TSH CalSet cobas e analyzer
Jan 12, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ELECSYS TSH cobas e analyzer
Jan 11, 2024
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ELECSYS CA 19-9
Jan 5, 2024
- Manufacturer
- ROCHE DIAGNOSTICS (SUZHOU) LTD
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
ELECSYS CA 15-3 II
Jan 5, 2024
- Manufacturer
- ROCHE DIAGNOSTICS (SUZHOU) LTD
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COAGUCHEK INRange System
Dec 28, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
ELECSYS DIGIT 21-1
Dec 28, 2023
- Manufacturer
- ROCHE DIAGNOSTICS (SUZHOU) LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
ELECSYS CA 15-3 II
Dec 28, 2023
- Manufacturer
- ROCHE DIAGNOSTICS (SUZHOU) LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
ROCHE CARDIAC POC NT proBNP Control
Dec 27, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Calset PTH
Dec 27, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Calset II PTH
Dec 27, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Elecsys PTH
Dec 27, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PreciControl HCV Duo
Dec 21, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COAGUCHEK XS PT Test
Dec 21, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS PreciControl Rubella IgG Elecsys and cobas e analyzers
Dec 19, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
ELECSYS HCV Duo
Dec 19, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
COBAS Elecsys Insulin
Dec 18, 2023
- Manufacturer
- ROCHE DIAGNOSTICS (SUZHOU) LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PreciControl HBsAg II quant II Elecsys and cobas e analyzers
Dec 18, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Estradiol III
Dec 18, 2023
- Manufacturer
- ROCHE DIAGNOSTICS (SUZHOU) LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Roche CARDIAC POC NT-proBNP
Dec 18, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Elecsys sFlt-1 Elecsys and cobas e analyzers
Dec 17, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Rubella IgG Elecsys and cobas e analyzers
Dec 14, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
ETOH2 Ethanol Gen.2 cobas c system
Dec 14, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
TRIGL cobas c 111 Triglycerides
Dec 14, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PreciControl HBsAg II Elecsys and cobas e analyzers
Dec 14, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Cortisol II Elecsys and Cobas e Analyzers
Dec 14, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS VANC3 ONLINE TDM Vancomycin Gen.3 cobas c systems
Dec 14, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PHNY2 ONLINE TDM Phenytoin cobas c systems
Dec 13, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Combur10 Test M
Dec 13, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
VENTANA Anti-CD8 (SP239) Rabbit Monoclonal Primary Antibody
Dec 13, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS UA2 cobas c 111 Uric acid ver.2
Dec 13, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PreciControl Rubella IgM Elecsys and cobas e analyzers
Dec 13, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS UA2 Uric Acid ver.2 cobas c systems
Dec 8, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PreClean M Modular Analytics E170, cobas e 601 and cobas e 602 analyzers
Dec 8, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS ProCell M Modular Analytics E170, cobas e 601 and cobas e 602 analyzers
Dec 8, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS Elecsys Rubella IgM Elecsys and cobas e analyzers
Dec 8, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS CleanCell Elecsys and cobas e analyzers
Dec 5, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS GLUC3 Glucose HK Gen.3 Cobas Integra cobas c systems
Dec 5, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS PYP cobas c 111 Pyridoxal Phosphate
Dec 4, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS AAT2 Tina-quant α1 - Antitrypsin ver.2
Dec 4, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys IgE II Elecsys and cobas e analyzers
Dec 4, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS IRON2 Iron Gen.2 Cobas Integra cobas c systems
Dec 4, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS GGT-2 cobas c 111 y-Glutamyltransferase ver.2
Dec 2, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ASTL cobas c 111 Aspartate Aminotransferase
Dec 2, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS ISE Calibration Kit cobas c 111
Dec 2, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PreciControl Toxo IgM Elecsys and Cobas e Analyzers
Nov 30, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
CHE2 Cholinesterase Gen.2 Cobas Integra / cobas c systems
Nov 30, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA Anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody
Nov 29, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS Elecsys Rubella IgM cobas e analyzers
Nov 29, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
GLUC2 cobas c 111 Glucose HK
Nov 29, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
ProCell Elecsys and cobas e analyzers
Nov 29, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
ACCU-CHEK® Instant Wireless Blood Glucose Meter and Lancing Device
Nov 28, 2023
- Manufacturer
- ROCHE DIABETES CARE., INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS CREP2 cobas c 111 Creatinine plus ver.2
Nov 27, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS ALB2 cobas c 111 Albumin Gen.2
Nov 27, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS C.f.a.s. HbA1c Calibrator for automated systems
Nov 27, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys PlGF Elecsys and cobas e analyzers
Nov 27, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Syswash Elecsys and cobas e analyzers
Nov 27, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS TP2 cobas c 111 Total Protein Gen.2
Nov 27, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CHOL2 cobas c 111 Cholesterol Gen.2
Nov 27, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS AAGP2 Tina-quant a1-Acid Glycoprotein Gen.2 COBAS INTEGRA / cobas c systems
Nov 23, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS ALP2S cobas c 111 Alkaline Phosphatase acc. To IFC Gen.2
Nov 23, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS UREAL cobas c 111 Urea/BUN
Nov 23, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ACCU-CHEK Guide Set Wireless Blood Glucose Meter and Lancing Device
Nov 23, 2023
- Manufacturer
- SANMINA CORPORATION
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS AMYL2 cobas c 111 α-Amylase EPS ver.2
Nov 23, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PreciControl Cortisol Saliva Elecsys and cobas e analyzers
Nov 23, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Estradiol III CalSet Elecsys and cobas e analyzer
Nov 21, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PreciSet TDM II Roche Systems
Nov 21, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Estradiol III Elecsys and cobas e analyzers
Nov 21, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS C.f.a.s. IgA/IgM CSF Roche Systems
Nov 21, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CA 125 II CalSet II Elecsys and Cobas e Analyzers
Nov 17, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS SALI Salicylate cobas c systems
Nov 16, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS C.f.a.s. PAC Roche Systems
Nov 16, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
PHNO2 ONLINE TDM Phenobarbital cobas c systems
Nov 16, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Accu-Chek Guide Wireless Blood Glucose Meter Only
Nov 16, 2023
- Manufacturer
- SANMINA-SCI INDIA PVT LTD
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Elecsys CA 125 II Elecsys and cobas e analyzers
Nov 16, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COAGUCHEK XS PT Test PST
Nov 14, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
DIG ONLINE TDM Digoxin cobas c systems
Nov 13, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COMBUR10 Test M
Nov 13, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
ROCHE Urisys 1100 Urine Analyzer and Accessories
Nov 8, 2023
- Manufacturer
- 77 ELECTRONICS INSTRUMENT INDUSTRY LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS MG2 Magnesium Gen.2 cobas c systems
Nov 8, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
IGG-2 Tina-quant IgG Gen.2 cobas c systems
Nov 8, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS TRSF2 Tina-quant Transferrin ver.2 cobas c systems
Nov 8, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COMBUR3 Test
Nov 8, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS CARB4 ONLINE TDM Carbamazepine Gen.4 cobas c systems
Nov 8, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA Silver ISH DNP Detection Kit
Nov 8, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COMBUR 10 Test UX
Nov 8, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS U Pack
Nov 8, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
VENTANA Red ISH DIG Detection Kit
Nov 6, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEM INC
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
ULTRA Cell Conditioning Solution (ULTRA CC1)
Nov 4, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
ULTRA LCS (Predilute)
Nov 4, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC., USA
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
ULTRA Cell Conditioning Solution (ULTRA CC2)
Nov 2, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS TOXO IgG Avidity Elecsys and cobas e analyzers
Oct 31, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Elecsys Toxo IgG Avidity cobas e analyzers
Oct 31, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Elecsys Toxo IgM cobas e analyzers
Oct 31, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
Acid Wash cobas c systems
Oct 31, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
Elecsys IgE II
Oct 31, 2023
- Manufacturer
- ROCHE DIAGNOSTICS (SUZHOU) LTD
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PreciControl Toxo IgG Avidity Elecsys and cobas e analyzers
Oct 31, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
ISETROL Level 1, 2, 3
Oct 25, 2023
- Manufacturer
- BIONOSTICS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COMBITROL Plus B Level 1
Oct 25, 2023
- Manufacturer
- BIONOSTICS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COMBITROL Plus B Level 2
Oct 20, 2023
- Manufacturer
- BIONOSTICS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys IgE II
Oct 20, 2023
- Manufacturer
- ROCHE DIAGNOSTICS (SUZHOU) LTD
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COAGUCHEK XS PT Controls
Oct 19, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS FERR4 Tina-quant Ferritin Gen.4 cobas c systems
Oct 13, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ELECSYS HE4
Oct 13, 2023
- Manufacturer
- ROCHE DIAGNOSTICS (SUZHOU) LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS IGA-2 Tina-quant IgA Gen.2 cobas c systems
Oct 13, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
IGM-2 Tina-quant IgM Gen.2 cobas c systems
Oct 13, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS ACET2 ONLINE TDM Acetaminophen Gen.2 cobas c systems
Oct 13, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
START Antigen Excess Reagent cobas c systems
Oct 12, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS PYP Pyridoxal phosphate cobas c systems
Oct 11, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
SCCS Special Cell Cleaning Solution cobas c systems
Oct 10, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
SI2 Sample Index Gen.2 cobas c systems
Oct 10, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS A1CD Hemolyzing reagent cobas c systems
Oct 9, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ELECSYS CA 125 II
Oct 9, 2023
- Manufacturer
- ROCHE DIAGNOSTICS (SUZHOU) LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
ELECSYS CA 125 II
Oct 9, 2023
- Manufacturer
- ROCHE DIAGNOSTICS (SUZHOU) LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS NACL Diluent NaCl 9% cobas c systems
Oct 9, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ELECSYS CA 19-9
Oct 9, 2023
- Manufacturer
- ROCHE DIAGNOSTICS (SUZHOU) LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
CRPHS Cardiac C-Reactive Protein (Latex) High Sensitive cobas c systems
Oct 4, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ECO-D EcoTergent cobas c systems
Oct 4, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
FSH Calset II
Sep 26, 2023
- Manufacturer
- ROCHE DIAGNOSTIC GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
AMY-P alfa-Amylase EPS Pancreatic cobas c systems
Sep 26, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
LH Calset II
Sep 26, 2023
- Manufacturer
- ROCHE DIAGNOSTIC GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS ALP2 Alkaline Phosphatase acc. to IFCC Gen.2 cobas c systems
Sep 24, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
NAOHD Detergent 1 cobas c systems
Sep 22, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS ALTP Alanine Aminotransferase PyP cobas c systems
Sep 20, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS u pack cobas u 601 analyzers
Sep 20, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS u Calibration Strip
Sep 20, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
AMYL2 alpha-Amylase EPS ver.2 cobas c systems
Sep 18, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Basic Wash cobas c systems
Sep 15, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
Ventana Anti-PRAME (EPR20330) Rabbit Monoclonal Primary Antibody
Sep 7, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
Ventana PTEN (SP218) Rabbit Monoclonal Primary Antibody
Sep 7, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
CKMB Creatine Kinase-MB cobas c systems
Aug 28, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ASTP Aspartate Aminotransferase PyP cobas c systems
Aug 23, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS UREAL Urea/BUN cobas c systems
Aug 18, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PreciControl Universal Elecsys and Cobas e Analyzers
Aug 14, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CK Creatine Kinase cobas c systems
Aug 9, 2023
- Manufacturer
- ROCHE DIAGNOSTICS, LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS LDHI2 Lactate Dehydrogenase acc. To IFCC ver.2 cobas c systems
Aug 9, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
GGT-2 Gamma-Glutamyltransferase ver.2 cobas c systems
Aug 7, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
TRIGL Triglycerides cobas c systems
Aug 7, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
PHOS2 Phosphate (Inorganic) ver.2 cobas c systems
Aug 3, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
TPUC3 Total Protein Urine/CSF Gen.3 cobas c systems
Aug 1, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ACCU-CHEK Safe-T-Pro Uno
Jul 28, 2023
- Manufacturer
- ROCHE DIABETES CARE GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS® GLU test strips
Jul 27, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS LDLC3 LDL-Cholesterol Gen.3 cobas c systems
Jul 26, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ACCU-CHEK Softclix
Jul 25, 2023
- Manufacturer
- ROCHE DIABETES CARE GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
HDLC4 HDL-Cholesterol Gen.4 cobas c systems
Jul 24, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Progesterone Diluent
Jul 20, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Control Set DAT Clinical
Jul 18, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS sTfR Control Set Roche Systems
Jul 18, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Cobas® GLU QC Kit
Jul 17, 2023
- Manufacturer
- BIONOSTICS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CREJ2 Creatinine Jaffe Gen.2 cobas c systems
Jul 12, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
GLUC3 Glucose HK Gen.3 cobas c systems
Jul 12, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
VENTANA INFORM EBER (Epstein-Barr Virus Early RNA) Probe
Jul 12, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
ACCU-CHEK Performa and Accessories
Jul 12, 2023
- Manufacturer
- SANMINA-SCI INDIA PVT LTD
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
CHOL2 Cholesterol Gen.2 cobas c systems
Jul 11, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
APOAT Tina-quant Apolipoprotein A-1 ver.2 cobas c systems
Jul 11, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ACCU-CHEK FastClix Lancets
Jul 10, 2023
- Manufacturer
- GERRESHEIMER REGENSBURG, GMBH
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS® SARS-CoV-2 Qualitative Control Kit
Jul 9, 2023
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS A1CX3 Tina-quant Hemoglobin A1cDx Gen.3 cobas c systems
Jul 9, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS SARS-CoV-2 & Influenza A/B Control Kit
Jul 9, 2023
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS LIPC Lipase colorimetric cobas c systems
Jul 6, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS APOBT Tina-quant Apolipoprotein B ver.2 cobas c systems
Jul 6, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS® SARS-CoV-2 Qualitative
Jul 4, 2023
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PCR Media Dual Swab Sample Kit
Jul 3, 2023
- Manufacturer
- ROCHE DIAGNOSTICS (SUZHOU) LTD
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS® MTB-RIF/INH Positive Control Kit
Jun 30, 2023
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
Cobas PCR Urine Sample Kit
Jun 30, 2023
- Manufacturer
- ROCHE DIAGNOSTICS (SUZHOU) LTD
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
cobas MTB Positive Control Kit
Jun 26, 2023
- Manufacturer
- ROCHE MOLECULAR SYSTEM, INC., USA
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS SARS-CoV-2 & Influenza A/B
Jun 22, 2023
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Cobas b 123 (2) POC System
Jun 21, 2023
- Manufacturer
- ROCHE DIAGNOSTICS INTERNATIONAL LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS b 123 < 1 > POC System
Jun 21, 2023
- Manufacturer
- ROCHE DIAGNOSTICS INTERNATIONAL LTD
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS® BKV
Jun 17, 2023
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
WINDOW 10X SSC
Jun 16, 2023
- Manufacturer
- ROCHE DIAGNOSTICS (SUZHOU) LTD
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
CO2-L Bicarbonate Liquid cobas c systems
Jun 16, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA Reaction Buffer Concentrate (10X)
Jun 16, 2023
- Manufacturer
- ROCHE DIAGNOSTICS (SUZHOU) LTD
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS Preciset sTfR Roche Systems
Jun 16, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CREP2 Creatinine plus ver.2 cobas c systems
Jun 16, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
LCS (Predilute)
Jun 13, 2023
- Manufacturer
- ROCHE DIAGNOSTICS (SUZHOU) LTD
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
ULTRA LCS (Predilute)
Jun 13, 2023
- Manufacturer
- ROCHE DIAGNOSTICS (SUZHOU) LTD
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS ALB2 Albumin Gen.2 cobas c systems
Jun 9, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS TP2 Total Protein Gen.2 cobas c systems
Jun 9, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CA2 Calcium Gen.2 cobas c systems
Jun 9, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS BILT3 Bilirubin Total Gen.3 cobas c systems
Jun 9, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS LIPC Lipase colorimetric cobas c systems
Jun 9, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Urine Diluent
Jun 6, 2023
- Manufacturer
- ROCHE DIAGNOSTICS INTERNATIONAL LTD
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS LDHI2 Lactate Dehydrogenase acc. TO IFCC ver.2 cobas c systems
Jun 4, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Tg II CalSet Elecsys and cobas e analyzers
Jun 4, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
BENCHMARK XT AND Accessories
Jun 1, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS MAI Positive control kit
Jun 1, 2023
- Manufacturer
- ROCHE MOLECULAR SYSTEM, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
cobas MAY
May 30, 2023
- Manufacturer
- ROCHE MOLECULAR SYSTEM, INC., USA
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Cobas® MTB-RIF/INH
May 29, 2023
- Manufacturer
- ROCHE MOLECULAR SYSTEM, INC., USA
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS 5800 System and Accessories
May 28, 2023
- Manufacturer
- ROCHE DIAGNOSTICS INTERNATIONAL LTD
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA Confirm anti-Topoisomerase II Alpha (JS5B4) Rabbit Monoclonal Primary Antibody
May 25, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA UltraView Silver Wash II
May 24, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
CalSet IGFBP-3
May 23, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA Confirm Anti-Ki-67 (30-9) Rabbit Monoclonal Primary Antibody
May 23, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA Confirm anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody
May 23, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS CalSet FT4 III Elecsys and Cobas e Analyzers
May 23, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA Cell Conditioning Solution (CC1)
May 22, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS MTB
May 20, 2023
- Manufacturer
- ROCHE MOLECULAR SYSTEM, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA Antibody Diluent
May 20, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS® Microbial Inactivation Solution
May 20, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH. CENTRALISED AND POINT OF CARE SOLUTIONS
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody
May 20, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA LCS (Predilute)
May 20, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA Amplification Kit
May 20, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA CONFIRM anti-Vimentin (V9) Primary Antibody
May 17, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody
May 16, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA Cell Conditioning Solution (CC2)
May 16, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA Reaction Buffer Concentrate (10X)
May 12, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.,
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
WINDOW Hematoxylin II
May 12, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA ISH Protease 1
May 12, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA ISH Protease 2
May 12, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA Protease 3
May 10, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA EZ Prep Concentrate (10X)
May 10, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS b 123 (4) POC System
May 5, 2023
- Manufacturer
- ROCHE DIAGNOSTICS INTERNATIONAL LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
ACCU-CHEK FastClix Lancets
May 5, 2023
- Manufacturer
- WEIDMANN MEDICAL TECHNOLOGY AG
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
Combur 10 Test M
May 5, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS NAOHD Detergent 1 cobas c systems
May 4, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS SMS Detergent 2 cobas c systems
Apr 28, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS Sample Cleaner 2 cobas c systems
Apr 28, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
Sample Cleaner 1 cobas c systems
Apr 28, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
ELECSYS FT4 IV
Apr 25, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS KAPP2
Apr 20, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
PreciControl HCC V2
Apr 20, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Reference Electrode COBAS INTEGRA ISE Modules
Apr 20, 2023
- Manufacturer
- ROCHE DIAGNOSTICS INTL, LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
CALSET GDF-15
Apr 20, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Cobas HIV-1/HIV-2 Qualitative
Apr 18, 2023
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
VENTANA CONFIRM anti-Calretinin (SP65) Rabbit Monoclonal Primary Antibody
Apr 6, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA anti-CD43 (L60) Mouse Monoclonal Primary Antibody
Apr 6, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
Cl- Electrode COBAS INTEGRA ISE Modules
Apr 5, 2023
- Manufacturer
- ROCHE DIAGNOSTICS INTL, LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
cobas EBV/BKV Control Kit
Apr 4, 2023
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
Cobas® EBV
Apr 4, 2023
- Manufacturer
- ROCHE MOLECULAR SYSTEM, INC., USA
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
VENTANA CONFIRM anti-EMA (E29) Mouse Monoclonal Primary Antibody
Apr 3, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA HE 600 Systems and Accessories
Apr 3, 2023
- Manufacturer
- Ventana Medical Systems Inc.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS D-DI2 Tina-quant D-Dimer Gen.2 Cobas Integra / Cobas c Systems
Mar 31, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COAGUCHEK XS System AND Accessories
Mar 30, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Roche Cardiac proBNP+
Mar 30, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
cobas HPV
Mar 29, 2023
- Manufacturer
- ROCHE MOLECULAR SYSTEM, INC., USA
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
ELECSYS FT4 III Elecsys and cobas e analyzer
Mar 28, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Na+ Electrode COBAS INTEGRA ISE Modules
Mar 27, 2023
- Manufacturer
- ROCHE DIAGNOSTICS INTL, LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS® PCR Media Dual Swab Sample Kit
Mar 27, 2023
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
cobas HPV Positive control Kit
Mar 27, 2023
- Manufacturer
- ROCHE MOLECULAR SYSTEM, INC., USA
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
K+ Electrode COBAS INTEGRA ISE Modules
Mar 26, 2023
- Manufacturer
- ROCHE DIAGNOSTICS INTL, LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS HbA1c Test cobas b 101
Mar 24, 2023
- Manufacturer
- PANASONIC HEALTHCARE CO., LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Toxo IgM Elecsys and Cobas e Analyzers
Mar 24, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS BILT3 Bilirubin Total Gen.3 cobas c 111
Mar 24, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CalSet II PTH cobas e analyzers
Mar 22, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Elecsys Toxo IgG Elecsys and cobas e analyzers
Mar 22, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS PreciControl Toxo IgG Elecsys and cobas e analyzers
Mar 22, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
Elecsys PIVKA-II cobas e analyzers
Mar 22, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS NH3L cobas c 111 Ammonia
Mar 16, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS 6000 c 501 and Accessories
Mar 16, 2023
- Manufacturer
- HITACHI HIGH TECHNOLOGIES CORPORATION.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PreciControl Active B12
Mar 10, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS ALP2 Alkaline Phosphatase acc to IFCC Gen.2 cobas c systems
Mar 10, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS IGM-C Tina-quant IgM CSF cobas c systems
Mar 10, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS AST Aspartate Aminotransferase cobas c systems
Mar 10, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GmbH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS C.f.a.s (Calibrator FOR automated systems)
Mar 10, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA CONFIRM anti-CD99 (O13) Mouse Monoclonal Primary Antibody
Mar 10, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
CINTEC p16 Histology
Mar 10, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CT/NG Positive Control Kit
Mar 7, 2023
- Manufacturer
- ROCHE MOLECULAR SYSTEM, INC., USA
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS TV/MG
Mar 7, 2023
- Manufacturer
- ROCHE MOLECULAR SYSTEM, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
cobas CT/NG
Mar 6, 2023
- Manufacturer
- ROCHE MOLECULAR SYSTEM, INC., USA
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
Cobas Plasma Separation Card
Mar 6, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Testosterone II CalSet II Elecsys and Cobas e Analyzers
Mar 3, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CRPHS Cardiac C Reactive Protein (Latex) High Sensitive Cobas Integra / Cobas c Systems
Mar 2, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS D-Dimer Gen.2 Control I/II
Mar 2, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS TV/MG Positive Control Kit
Mar 2, 2023
- Manufacturer
- ROCHE MOLECULAR SYSTEM, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS D-Dimer Gen.2 Calibrator SET Roche Systems
Mar 2, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GmbH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA Bluing Reagent
Mar 1, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA Hematoxylin
Mar 1, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA ISH Protease 3
Mar 1, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA OptiView Amplification Kit
Feb 26, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA UltraView Universal DAB Detection Kit
Feb 26, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA Rabbit Monoclonal Negative Control Ig
Feb 24, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEM INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
CalSet Active B12
Feb 23, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ACCU-CHEK FastClix Lancing Device
Feb 20, 2023
- Manufacturer
- BALDA MEDICAL GMBH
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA OptiView DAB IHC Detection Kit
Feb 17, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS MTB Positive Control Kit for use on the cobas 6800/8800 Systems
Feb 17, 2023
- Manufacturer
- ROCHE MOLECULAR SYSTEMS
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
WINDOW 10X SSC
Feb 17, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA CONFIRM anti-Kappa Rabbit Polyclonal Primary Antibody
Feb 17, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS ACTH Calset Elecsys and Cobas e Analyzers
Feb 16, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS MTB Nucleic acid test for use on the cobas 6800/8800 Systems
Feb 15, 2023
- Manufacturer
- ROCHE MOLECULAR SYSTEMS
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Elecsys Prolactin II Elecsys and Cobas e Analyzers
Feb 10, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA CONFIRM anti-CD34 (QBEnd/10) Primary Antibody
Feb 9, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS Elecsys ACTH Elecsys and Cobas e Analyzers
Feb 9, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Anti-HCV II cobas e analyzers
Feb 8, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
COBAS AMYL 2 a-Amylase EPS ver.2 COBAS INTEGRA / Cobas c Systems
Feb 7, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS FERR4 Tina-quant Ferritin Gen.4 Cobas c Systems
Feb 7, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA CONFIRM anti-Prostate Specific Antigen (PSA) Rabbit Polyclonal Primary Antibody
Feb 7, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Prolactin II Calset Elecsys and Cobas e Analyzers
Jan 30, 2023
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA CONFIRM anti-Keratin (34βE12) Mouse Monoclonal Primary Antibody
Jan 25, 2023
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS Sodium Electrode Conditioner
Dec 27, 2022
- Manufacturer
- ROCHE DIAGNOSTICS INTL, LTD.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA Confirm anti-Synaptophysin (SP11) Rabbit Monoclonal Primary Antibody
Dec 19, 2022
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA anti-Cytokeratin 5/6 (D5/16B4) Mouse Monoclonal Primary Antibody
Dec 19, 2022
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS ProGRP CalSet
Dec 15, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PreciControl HbA1c norm
Dec 8, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody
Dec 8, 2022
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys FT3 III Elecsys and Cobas e Analyzers
Dec 8, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA CONFIRM anti-CD15 (MMA) Mouse Monoclonal Primary Antibody
Dec 8, 2022
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Lipid Panel CHOL-TRIGL-HDL-LDL cobas b 101
Dec 6, 2022
- Manufacturer
- PHC CORPORATION
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS UIBC Unsaturated Iron-Binding Capacity Cobas c Systems
Dec 6, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS ALB2 Albumin Gen.2 Cobas c Systems
Dec 6, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys HIV Combi PT Elecsys and Cobas e Analyzers
Dec 6, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
COBAS® HBV/HCV/HIV-1 Control Kit for Cobas 6800/8800
Nov 30, 2022
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
CINTEC PLUS Cytology Kit
Nov 30, 2022
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS UA2 Uric Acid ver.2 Cobas C Systems
Nov 30, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Syphilis Elecsys and Cobas e Analyzers
Nov 25, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS AMPII ONLINE DAT Amphetamines II Cobas Integra
Nov 25, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Tacrolimus Elecsys and Cobas e Analyzers
Nov 18, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Cyclosporine CalSet Elecsys and Cobas e Analyzer
Nov 18, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PreciControl Syphilis Elecsys and Cobas e Analyzers
Nov 18, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS PreciControl HSV Elecsys and Cobas e Analyzers
Nov 18, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
VENTANA anti-c-MYC (Y69) Rabbit Monoclonal Primary Antibody
Nov 16, 2022
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS Cystatin C Control Set Gen.2 Roche systems
Nov 14, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ROCHE Elecsys Cyclosporine Elecsys and cobas e Analyzers
Nov 14, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Elecsys Calcitonin Elecsys and cobas e analyzers
Nov 8, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys BRAHMS PCT cobas e analyzers
Nov 7, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Z 480 and Accessories
Nov 7, 2022
- Manufacturer
- ROCHE DIAGNOSTICS INTL, LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PreciControl ClinChem Multi 2 Roche Systems
Nov 7, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CYSC2 Tina-quant Cystatin C Gen.2 COBAS INTEGRA / Cobas C Systems
Nov 7, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PreciControl HbA1c Path Roche Systems
Nov 7, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA anti-CD30 (Ber-H2) Mouse Monoclonal Primary Antibody
Nov 1, 2022
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA anti-Thyroid Transcription Factor-1 (SP141) Rabbit Monoclonal Primary Antibody
Oct 31, 2022
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA CONFIRM anti-CD8 (SP57) Rabbit Monoclonal Primary Antibody
Oct 31, 2022
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Homocysteine Calibrator Kit
Oct 27, 2022
- Manufacturer
- DIAZYME LABORATORIES.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody
Oct 27, 2022
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA CONFIRM anti-Cytokeratin 7 (SP52) Rabbit Monoclonal Primary Antibody
Oct 27, 2022
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA anti-bcl-2 (SP66) Rabbit Monoclonal Primary Antibody
Oct 27, 2022
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA CONFIRM anti-bcl-2 (124) Mouse Monoclonal Primary Antibody
Oct 25, 2022
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA Basal Cell Cocktail (34 Beta E12+p63)
Oct 24, 2022
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA CONFIRM anti-CD4 (SP35) Rabbit Monoclonal Primary Antibody
Oct 24, 2022
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA Confirm Anti-Cytokeratin 20 (SP33) Rabbit Monoclonal Primary Antibody
Oct 20, 2022
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA CONFIRM anti-CD5 (SP19) Rabbit Monoclonal Primary Antibody
Oct 20, 2022
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA CONFIRM anti-PAX5 (SP34) Rabbit Monoclonal Primary Antibody
Oct 19, 2022
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA anti-p40 (BC28) Mouse Monoclonal Primary Antibody
Oct 18, 2022
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA CONFIRM anti-Desmin (DE-R-11) Primary Antibody
Oct 18, 2022
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA anti-CD7 (SP94) Rabbit Monoclonal Primary Antibody
Oct 18, 2022
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS 6800 Systems
Oct 11, 2022
- Manufacturer
- ROCHE DIAGNOSTICS INTERNATIONAL LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS IL-6 CalSet Elecsys and cobas e analyzers
Oct 6, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS HBDH2 COBAS INTEGRA / Cobas c Systems
Oct 6, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS TROPONIN T hs STAT CalSet Elecsys and cobas e analyzers
Oct 6, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS ALBT2 cobas c 111 Tina-quant
Oct 6, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS LPA2 Tina-quant Lipoprotein (a) Gen.2 COBAS INTEGRA / Cobas c Systems
Oct 6, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PreciControl ISD Elecsys and Cobas e Analyzers
Oct 6, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PreciControl ThyroAB Elecsys and Cobas e Analyzers
Sep 28, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS AMPS2 ONLINE DAT Amphetamines II Cobas c Systems
Sep 26, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PreciControl ClinChem Multi 1 Roche Systems
Sep 26, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS MPX Multiplex HIV, HCV & HBV nucleic acid test for use on the cobas 6800/8800 Systems
Sep 21, 2022
- Manufacturer
- ROCHE MOLECULAR SYSTEM, INC.
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
Elecsys ProGRP Elecsys and Cobas e Analyzers
Sep 20, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Preciset Lp(a) Gen.2
Sep 19, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS NaCl Diluent 9% cobas c 111
Sep 16, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CalSet PTH Elecsys and Cobas e Analyzers
Sep 16, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS ALB2 Albumin Gen.2 COBAS INTEGRA / Cobas c Systems
Sep 16, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CRP T Control N Roche Systems
Sep 16, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Serum Proteins T Standard Roche Systems
Sep 12, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS HbA1c Control
Sep 12, 2022
- Manufacturer
- CANTERBURY SCIENTIFIC LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Clean Cobas c 111
Sep 12, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS Tacrolimus CalSet Elecsys and Cobas e Analyzers
Sep 12, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PreciControl Lp(a) Gen.2 Roche Systems
Sep 12, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS BILT3 Bilirubin Total Gen.3 COBAS INTEGRA / Cobas c Systems
Sep 12, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PreciControl Growth Elecsys and cobas e analyzers
Sep 8, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS® CMV Control Kit
Sep 8, 2022
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS ISD Sample Pretreatment Elecsys and Cobas e Analyzers
Sep 1, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
VENTANA Confirm anti-CD20 (L26) Primary Antibody
Aug 29, 2022
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA Confirm anti-p53 (DO-7) Primary Antibody
Aug 26, 2022
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA CONFIRM anti-S100 (4C4.9) Primary Antibody
Aug 25, 2022
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
VENTANA CONFIRM anti-CD45, LCA (RP2/18) Primary Antibody
Aug 25, 2022
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA PD-L1 (SP263) Assay
Aug 25, 2022
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
VENTANA Anti-Pan Keratin (AE1/AE3/PCK26) Primary Antibody
Aug 23, 2022
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA Confirm anti-CD3 (2GV6) Rabbit Monoclonal Primary Antibody
Aug 23, 2022
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA PD-L1 (SP142) Assay
Aug 23, 2022
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS STFR2 Tina-quant Soluble Transferrin Receptor II cobas c systems
Aug 23, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
MagNA Pure DNA Tissue Lysis Buffer
Aug 23, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS MPX Control Kit Positive Control Kit for Use on The Cobas 6800/8800 Systems
Aug 16, 2022
- Manufacturer
- ROCHE MOLECULAR SYSTEM, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CalSet IGF-1 Elecsys and cobas e analyzers
Aug 11, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ACCU-CHEK Active Test Strips
Aug 9, 2022
- Manufacturer
- ROCHE DIABETES CARE GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
cobas SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas Liat Systems
Aug 9, 2022
- Manufacturer
- ROCHE MOLECULAR SYSTEMS
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ACCU-CHEK Linearity Test Kit
Aug 5, 2022
- Manufacturer
- BIONOSTICS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Precicontrol HIV Gen II Elecsys and cobas e analyzers
Aug 4, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ROCHE Cell Collection Medium Kit
Jul 27, 2022
- Manufacturer
- TERMO FISHER SCIENTIFIC INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
cobas SARS-CoV-2 & Influenza A/B Quality Control Kit for use on the cobas Liat Systems
Jul 22, 2022
- Manufacturer
- ROCHE MOLECULAR SYSTEMS INC
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
SD BIOSENSOR SARS-CoV-2 Rapid Antigen Test
Jul 22, 2022
- Manufacturer
- SD BIOSENSOR
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS® PCR Media Uni Swab Sample kit
Jul 22, 2022
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS Ammonia/Ethanol/CO2 Control Abnormal Roche Systems
Jul 18, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Digoxin cobas e analyzers
Jul 14, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Elecsys HSV-1 IgG cobas e analyzers
Jul 1, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS HBV
Jun 27, 2022
- Manufacturer
- ROCHE MOLECULAR SYSTEMS
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
COBAS Elecsys Anti-HBc IgM cobas e analyzers
Jun 27, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
COBAS NHP Negative Control Kit
Jun 23, 2022
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS IRON2 cobas c 111 Iron Gen.2
Jun 23, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
CELL WASH Solution I / NAOH-D Roche/ Hitachi
Jun 22, 2022
- Manufacturer
- TERMO FISHER SCIENTIFIC (SUZHOU) INSTRUMENTS CO., LTD.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS Elecsys PIGF Elecsys and cobas e analyzers
Jun 21, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Homocysteine Control Kit
Jun 21, 2022
- Manufacturer
- DIAZYME LABORATORIES.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA anti-CD117 (EP10) Rabbit Monoclonal Primary Antibody
Jun 21, 2022
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
CleanCell M MODULAR ANALYTICS E170 and cobas e analyzers
Jun 21, 2022
- Manufacturer
- TERMO FISHER SCIENTIFIC (SUZHOU) INSTRUMENTS CO., LTD.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS CA2 Calcium Gen.2 cobas c111
Jun 21, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ELECSYS Active B12 cobas e analyzers
Jun 17, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
MagNA Pure 96 Instrument and Accessories
Jun 14, 2022
- Manufacturer
- ROCHE DIAGNOSTICS INTERNATIONAL LTD.,
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Folate RBC CalSet Elecsys and cobas e analyzers
Jun 13, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Anti-HBc II cobas e analyzers
Jun 10, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
COBAS Elecsys Anti-HBe cobas e analyzers
Jun 1, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
COBAS Elecsys HCG STAT cobas e analyzers
May 30, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PreciControl CMV IgG Elecsys and cobas e analyzers
May 30, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS PreciControl CMV IgM Elecsys and cobas e analyzers
May 30, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS b 101 and Accessories
May 25, 2022
- Manufacturer
- PANASONIC HEALTHCARE CO., LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys HBeAg cobas e analyzers
May 25, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Roche Cardiac Poc Troponin T 2-Level Control Cobas h 232
May 24, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS MG2 Magnesium Gen.2 cobas c systems
May 22, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ACCUTREND Cholesterol
May 22, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS HIV-1 Quantitative nucleic acid test
May 20, 2022
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
COBAS IGA Tina-quant Immunoglobulin A Cobas Integra
May 20, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Cobas HCV (192 T)
May 20, 2022
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
COBAS IGM Tina-quant Immunoglobulin M Cobas Integra
May 19, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS IGGT Tina-quant Immunoglobulin G (Turbidimetric) Cobas Integra
May 19, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys HSV-2 IgG cobas e analyzers
May 17, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Elecsys HSV-1 IgG cobas e analyzers
May 17, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS PreciControl Troponin Elecsys and cobas e analyzers
May 16, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Precicontrol Multimarker Elecsys and cobas e analyzers
May 16, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Elecsys Folate RBC Elecsys and Cobas e Analyzers
May 12, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS sFlt-1 CalSet cobas e analyzers
May 12, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ACCU-CHEK Inform II
Apr 29, 2022
- Manufacturer
- ROCHE DIABETES CARE, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS PreciControl Maternal Care cobas e analyzers
Apr 28, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PIGF CalSet Elecsys and cobas e analyzers
Apr 28, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Anti-HBc II cobas e analyzers
Apr 27, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
COBAS Elecsys Troponin T hs STAT cobas e analyzers
Apr 25, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CalSet Troponin T hs cobas e analyzers
Apr 19, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Digitoxin cobas e analyzers
Apr 13, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CMV
Apr 11, 2022
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Ammonia/Ethanol/CO2 Control Normal Roche Systems
Apr 6, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
CA2 Calcium Gen.2 Cobas Integra / cobas c systems
Mar 31, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
TDM Control Set Roche Systems
Mar 31, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Ammonia/Ethanol/CO2 Calibrator Roche Systems
Mar 31, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ACCU-CHEK Instant Control
Mar 31, 2022
- Manufacturer
- BIONOSTICS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Eco-D Eco Tergent Cobas C 311 Systems
Mar 30, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS Cleaner COBAS INTEGRA COBAS C 111
Mar 30, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS cfDNA Sample Preparation Kit (cfDNA SP)
Mar 22, 2022
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA pan-TRK (EPR17341) Assay
Mar 14, 2022
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS T-Uptake Elecsys and cobas e analyzers
Feb 21, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Calcitonin CalSet Elecsys and cobas e analyzers
Jan 31, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
CALSET Folate cobas e analyzers
Jan 20, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
PreciControl Vitamin D total III cobas e analyzers
Jan 11, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Digitoxin CalSet Elecsys and cobas e analyzers
Jan 6, 2022
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Vitamin D total III cobas e analyzers
Dec 29, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
CalSet HCG STAT and cobas e analyzers
Dec 29, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CalSet Vitamin D total III cobas e analyzers
Dec 29, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Cobas CT/NG Qualitative nucleic acid test
Dec 15, 2021
- Manufacturer
- ROCHE MOLECULAR SYSTEMS INC.,
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS PCR Urine Sample Kit
Dec 10, 2021
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
HEMOLYZING Reagent Roche/ Hitachi
Dec 7, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS A1C-3 cobas c111 Tina-quant Hemoglobin A1c Gen.3
Dec 5, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS HDLC4 cobas c 111 HDL-Cholesterol Gen.4
Dec 5, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Fe Standard Roche Systems
Dec 5, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS HDLC4 HDL-Cholesterol Gen.4 COBAS INTEGRA/ cobas c systems
Dec 5, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS TP2 Total Protein Gen.2 COBAS INTEGRA / cobas c systems
Dec 5, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CMV IgM Elecsys and Cobas e Analyzers
Dec 5, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
ACCU-CHEK Instant Test Strips
Nov 29, 2021
- Manufacturer
- ROCHE DIABETES CARE, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
ACCU-CHEK Guide Control
Nov 25, 2021
- Manufacturer
- BIONOSTICS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS HPV Qualitative nucleic acid test for use on the cobas 6800/8800 systems
Nov 25, 2021
- Manufacturer
- ROCHE MOLECULAR SYSTEMS
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
ProCell II M cobas e 801
Nov 19, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
ACCU-CHEK Instant Linearity Test Kit
Nov 15, 2021
- Manufacturer
- BIONOSTICS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ACCU-CHECK Guide Test Strips
Nov 15, 2021
- Manufacturer
- ROCHE DIABETES CARE, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS SCC Elecsys and cobas e analyzers
Nov 11, 2021
- Manufacturer
- ROCHE DIAGNOSTICSGMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS FSH CalSet II Elecsys and cobas e analyzers
Nov 11, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ELECSYSβ-CrossLaps/Serum cobas e analyzers
Nov 2, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys FT3 III cobas e analyzers
Nov 2, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Elecsys Calcitonin cobas e analyzers
Oct 29, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PreciControl Vitamin D total II Elecsys and cobas e analyzers
Oct 23, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CalSet Myoglobin cobas e analyzers
Oct 23, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CK-MB CalSet Elecsys and cobas e analyzers
Oct 22, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys CK-MB Elecsys and cobas e analyzer
Oct 22, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Vitamin D Total II CalSet Elecsys and cobas e analyzers
Oct 18, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Troponin I cobas e analyzers
Oct 17, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Myoglobin cobas e analyzers
Oct 15, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Anti-HAV cobas e analyzers
Oct 11, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Diluent Universal cobas e analyzers
Oct 11, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys hGH cobas e analyzers
Sep 25, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Anti-HCV II cobas e analyzers
Sep 25, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Diluent MultiAssay cobas e analyzers
Sep 25, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
PRECLEAN II M cobas e 801
Sep 25, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
Free βhCG Calset Elecsys and cobas e analzyers
Sep 15, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
PreciControl SARS-CoV-2 Antigen cobas e analyzers
Sep 8, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS 8000 e 801 Module and Accessories
Sep 6, 2021
- Manufacturer
- HITACHI HIGH-TECHNOLOGIES CORPORATION.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Rubella IgG cobas e analyzers
Aug 27, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Elecsys HE4 cobas e analyzers
Aug 21, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Elecsys CMV IgM cobas e analyzers
Aug 21, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Elecsys CMV IgG Avidity cobas e analyzers
Aug 19, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Elecsys CK-MB cobas e analyzers
Aug 19, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Syphilis cobas e analyzers
Aug 18, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Elecsys CMV IgG cobas e analyzers
Aug 14, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Elecsys Sirolimus cobas e analyzers
Aug 12, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Elecsys Toxo IgG cobas e analyzers
Aug 12, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Elecsys CYFRA 21-1 cobas e analyzers
Aug 10, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Elecsys Everolimus cobas e analyzers
Aug 10, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Elecsys Vitamin D Total II cobas e analyzers
Aug 10, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Tacrolimus cobas e analyzers
Aug 10, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Elecsys Anti-TPO cobas e analyzers
Aug 7, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS SCC CalSet Elecsys and cobas e analyzers
Aug 7, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys ACTH cobas e analyzers
Aug 6, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Elecsys Anti-CCP cobas e analyzers
Aug 6, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Elecsys Folate III cobas e analyzers
Aug 5, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Calcitonin cobas e analyzers
Aug 4, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys N-MID Osteocalcin cobas e analyzers
Aug 4, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS HIV-1 Quantitative Nucleic Acid Test for Use on The cobas 4800 System (c4800 HIV-1 AMP/ DET)
Aug 4, 2021
- Manufacturer
- ROCHE MOLECULAR SYSTEMS.,INC
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
COBAS Elecsys Cyclosporine cobas e analyzers
Aug 3, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Elecsys IgE II cobas and analyzers
Jul 28, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS HBV Quantitative Nucleic Acid Test for Use on The Cobas 4800 System
Jul 27, 2021
- Manufacturer
- ROCHE MOLECULAR SYSTEMS INC.
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
COBAS Elecsys FT3 III cobas e analyzers
Jul 19, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Vitamin B12 II cobas e analyzers
Jul 16, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Tg II cobas and analyzers
Jul 15, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Cortisol II cobas e analyzers
Jul 15, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Anti-HAV IgM cobas e analyzers
Jul 15, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS SARS-CoV-2 Qualitative nucleic acid test for use on the cobas 6800/8800 systems
Jul 12, 2021
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys CA 72-4 cobas e analyzers
Jul 12, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Elecsys Insulin Cobas e Analyzers
Jul 10, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys LH cobas e analyzers
Jul 10, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS HCV Quantitative Nucleic Acid Test For Use On The Cobas 4800 System (c4800 HCV AMP/ DET)
Jul 9, 2021
- Manufacturer
- ROCHE MOLECULAR SYSTEMS,INC
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
COBAS Elecsys DHEA-S cobas e analyzers
Jul 6, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys C-Peptide cobas e analyzers
Jul 6, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Anti-Tg cobas e analyzers
Jul 2, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS h 232 and Accessories
Jun 24, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS HCV GT HCV genotyping test for use on the cobas 4800 System (c4800 HCV GT AMP/ DET)
Jun 24, 2021
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS 4800 System Specimen Diluent 2 (c4800 SD 2)
Jun 23, 2021
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS HCV GT Control Kit For Use On The Cobas 4800 System (c4800 HCV GT CTLS)
Jun 23, 2021
- Manufacturer
- ROCHE MOLECULAR SYSTEMS,INC
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys total P1NP cobas e analyzers
Jun 22, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS 4800 System Lysis Kit 2
Jun 22, 2021
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS HBV/HCV/HIV-1 Control Kit (c4800 HBV/HCV/HIV CTLS)
Jun 22, 2021
- Manufacturer
- ROCHE MOLECULAR SYSTEMS,INC
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS EGFR Mutation Test v2 (EGFR V2)
Jun 21, 2021
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Prolactin II cobas e analyzers
Jun 20, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys PTH cobas e analyzers
Jun 20, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys SHBG cobas e analyzers
Jun 20, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys CA 19-9 cobas e analyzers
Jun 17, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS 6000 e 601 and Accessories
Jun 17, 2021
- Manufacturer
- HITACHI HIGH-TECHNOLOGIES CORPORATION.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys T4 cobas e analyzers
Jun 17, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys AFP cobas e analyzers
Jun 17, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Ferritin cobas e analyzers
Jun 17, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys CEA cobas e analyzers
Jun 17, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS PreciControl Lung Cancer Elecsys and cobas e analyzers
Jun 16, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Elecsys FSH cobas e analyzers
Jun 16, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Estradiol III cobas e analyzers
Jun 16, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys NSE cobas e analyzers
Jun 16, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Elecsys T3 cobas e analyzers
Jun 16, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Anti-HBc II Elecsys and cobas e analyzers
Jun 16, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
COBAS Elecsys β-CrossLaps/serum cobas e analyzers
Jun 16, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Testosterone II cobas e analyzers
Jun 16, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PreciControl Anti-HBc II Elecsys and cobas e analyzers
Jun 10, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS GENT2 ONLINE TDM Gentamicin cobas c systems
Jun 10, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
SD BIOSENSOR SARS-CoV-2 Rapid Antibody Test
Jun 3, 2021
- Manufacturer
- SD BIOSENSOR
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS GLDH3 GLDH Gen.3 cobas c systems
May 29, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS 4800 CT / NG Controls Kit
May 24, 2021
- Manufacturer
- ROCHE MOLECULAR SYSTEMS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS 4800 CT / NG Amplification/Detection Kit
May 24, 2021
- Manufacturer
- ROCHE MOLECULAR SYSTEMS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS 4800 System Control Diluent Kit
May 24, 2021
- Manufacturer
- ROCHE MOLECULAR SYSTEMS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS ASTP2 Aspartate Aminotransferase acc. to IFCC II cobas systems
May 6, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS ALTP2 Alanine Aminotransferase acc. to IFCC II cobas systems
May 6, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Ampliprep/COBAS TaqMan HIV-1 Qualitative Tes, v2.0 (HI2QCAP)
Apr 19, 2021
- Manufacturer
- ROCHE MOLECULAR SYSTEM INC.
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
PreciControl HCC Elecsys and cobas e analyzers
Apr 9, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys GDF-15 cobas e analyzers
Mar 30, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CalSet PIVKA-II Elecsys and cobas e analyzers
Mar 17, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Elecsys Tg II cobas e analyzers
Mar 17, 2021
- Manufacturer
- ROCHE DIAGNOSTICS, LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS e 411 Analyzer (Rack System) and Accessories
Mar 13, 2021
- Manufacturer
- HITACHI HIGH-TECHNOLOGIES CORPORATION.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Tg II CalSet cobas e analyzers
Mar 9, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Elecsys T4 cobas e analyzers
Mar 9, 2021
- Manufacturer
- ROCHE DIAGNOSTICS, LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys T3 cobas e analyzers
Mar 9, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
MAGNA Pure 96 DNA Tissue Lysis Buffer
Mar 8, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Elecsys PIVKA-II Elecsys and cobas e analyzers
Mar 3, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS CKMB Creatine Kinase-MB cobas c111
Feb 26, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
HAPT2 Tina-quant Haptoglobin ver.2 Cobas Integra / cobas c systems
Feb 26, 2021
- Manufacturer
- ROCHE DIAGNOSTICS, LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
MagNA Pure 96 External Lysis Buffer
Feb 25, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
MagNA Pure 96 Bacterial Lysis Buffer
Feb 22, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CK Creatine Kinase COBAS INTEGRA / cobas c systems
Feb 22, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CK Creatine Kinase cobas c 111
Feb 19, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Li+ Electrode COBAS INTEGRA ISE Modules
Feb 18, 2021
- Manufacturer
- ROCHE DIAGNOSTICS INTL, LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CKMB Creatine Kinase-MB COBAS INTEGRA/cobas c systems
Feb 18, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CRP4 Tina-quant C-Reactive Protein IV cobas c systems
Feb 11, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
MagNA Pure 96 Instrument and Accessories
Feb 8, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS SARS-CoV-2 Control Kit Positive control kit for use on the cobas 6800/8800 Systems
Feb 5, 2021
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS LACT2 Lactate Gen.2 Cobas Integra / cobas c systems
Feb 1, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA UltraView Red ISH DIG Detection Kit
Jan 28, 2021
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
VENTANA UltraView SISH DNP Detection Kit
Jan 28, 2021
- Manufacturer
- VENTANA MEDICAL SYTEMS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
VENTANA anti-HER2/neu (4B5) Rabbit Monoclonal Prim
Jan 28, 2021
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS HCV Quantitative nucleic acid test for use on the cobas 6800/8800 systems
Jan 27, 2021
- Manufacturer
- ROCHE MOLECULAR SYSTEMS INC.
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
COBAS Elecsys Anti-HBc IgM Elecsys and cobas e analyzers
Jan 27, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.,
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
VENTANA INFORM HER 2 Dual ISH DNA Probe Cocktail
Jan 25, 2021
- Manufacturer
- VENTANA MEDICAL SYSTEMS SYSTEMS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
MagNA Pure 96 DNA and Viral NA Small Volume Kit
Jan 25, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
MagNA Pure 96 DNA and Viral NA Large Volume Kit
Jan 25, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS Preciset TDM I Roche Systems
Jan 20, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ELECSYS Anti-CCP Elecsys and cobas e analyzers
Jan 20, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS PAPP-A CalSet Elecsys and cobas e analyzers
Jan 20, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Precipath Fructosamine Roche Systems
Jan 20, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Precinorm Fructosamine Roche Systems
Jan 20, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Precimat Fructosamine Roche Systems
Jan 20, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS C.f.a.s. Cystatin C Roche Systems
Jan 19, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS ECO-D Roche/Hitachi Cobas c 501/502 Analyzer
Jan 19, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS AFP Calset II Elecsys and cobas e analyzers
Jan 19, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ELECYS Insulin Elecsys and Cobas e Analyzers
Jan 19, 2021
- Manufacturer
- ROCHE DIAGNOSTICS, LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Folate III CalSet Elecsys and cobas e analyzers
Jan 19, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Total P1NP Elecsys and cobas e analyzers
Jan 19, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS APOAT Tina-quant Apolipoprotein A-1 ver.2 Cobas Integra / cobas c systems
Jan 19, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS ISE Diluent Gen.2 Roche/Hitachi
Jan 19, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS APOBT Tina-quant Apolipoprotein B ver.2 Cobas Integra / cobas c systems
Jan 19, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS SCCS (Special Cell Cleaning Solution) cobas c systems
Jan 16, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS PreciControl Anti-CCP Elecsys and cobas e analyzers
Jan 16, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS ISE Deproteinizer Cobas c 111
Jan 16, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS Elecsys T3 Elecsys and Cobas e Analyzers
Jan 15, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS C-Peptide CalSet Elecsys and cobas e analyzers
Jan 15, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS A1C-3 Tina-quant [a] Hemoglobin A1c Gen.3 Cobas Integra / Cobas c Systems
Jan 15, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ELECSYS Testosterone II Elecsys and Cobas e Analyzers
Jan 15, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS NACL Diluent NaCI 9% cobas c systems
Jan 13, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS HIV Combi PT Elecsys and Cobas e Analyzer
Jan 11, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
COBAS ASTL Aspartate Aminotransferase Cobas Integra / cobas c systems
Jan 4, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys AMH Plus cobas e analyzers
Jan 4, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CRPHS cobas c 111 Cardiac C-Reactive Protein (Latex) High Sensitive
Jan 4, 2021
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS T4 Elecsys and cobas e analyzers
Dec 30, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS INTEGRA 400 Plus and Accessories
Dec 30, 2020
- Manufacturer
- ROCHE DIAGNOSTICS INTL., LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS HCG+β CalSet Elecsys and Cobas e Analyzer
Dec 30, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS ISE Internal Standard Gen.2 Roche/Hitachi
Dec 30, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys HBsAg Confirmatory Test Elecsys and cobas e analyzers
Dec 28, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
COBAS Elecsys Ferritin Elecsys and cobas e analyzers
Dec 28, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
CO2-L Bicarbonate Liquid COBAS INTEGRA/cobas c systems
Dec 26, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PreciControl Anti-HBs Elecsys and cobas e analyzers
Dec 26, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CERU Ceruloplasmin COBAS INTEGRA / cobas c systems
Dec 26, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PreciControl Anti-HBc IgM Elecsys and cobas e analyzers
Dec 26, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS GLUC2 Glucose HK Cobas Integra cobas c systems
Dec 21, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS N-MID Osteocalcin CalSet cobas e analyzers
Dec 18, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PREA Prealbumin Cobas Integra / cobas c systems
Dec 17, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS ISE Cleaning Solution / Elecsys SysClean Roche Systems
Dec 15, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS C3C-2 Tina-quant Complement C3c ver.2 Cobas Integra / cobas c systems
Dec 11, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Precipath PUC Roche Systems
Dec 11, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys C-Peptide Elecsys and Cobas e analyzers
Dec 11, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Hemolyzing Reagent Gen.2 Cobas Integra
Dec 11, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS LIPC Lipase Colorimetric COBAS INTEGRA / Cobas c systems
Dec 10, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
C.f.a.s. Proteins Calibrator for Automated Systems
Dec 10, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS C4-2 Tina-quant Complement C4 ver.2 Cobas Integra/cobas c systems
Dec 10, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Diluent MultiAssay Elecsys and Cobas e analyzers
Dec 7, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Preciset RF Roche / Hitachi
Dec 4, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Elecsys AFP Elecsys and cobas e analyzers
Dec 3, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS PRECINORM PUC Roche Systems
Dec 1, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
NaCl Diluent 9% Cobas Integra
Dec 1, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS Precipath Protein Roche Systems
Dec 1, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS GGT-2 y-Glutamyl-transferase ver.2 COBAS INTEGRA / cobas c systems
Dec 1, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys CEA Elecsys and cobas e analyzers
Dec 1, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS C.f.a.s. Lipids Calibrator For Automated Systems
Dec 1, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
C.f.a.s. CK-MB Calibrator for automated systems
Nov 29, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
TRIGL Triglycerides COBAS INTEGRA / cobas c systems
Nov 29, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys SHBG Elecsys and cobas e analyzers
Nov 29, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS SHBG CalSet Elecsys and cobas e analyzers
Nov 26, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Total P1NP CalSet Elecsys and Cobas e Analyzers
Nov 26, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CHOL2 Cholesterol Gen.2 COBAS INTEGRA / Cobas c systems
Nov 26, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PreciControl Anti-HCV Elecsys and cobas e analyzers
Nov 22, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Sirolimus CalSet Elecsys and cobas e analyze
Nov 22, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Everolimus CalSet Elecsys and cobas e analyzers
Nov 22, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS UA2 Uric Acid ver.2 Cobas Integra / cobas c systems
Nov 22, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS hGH Calset Elecsys and cobas e analyzers
Nov 22, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS C.f.a.s PUC Roche Systems
Nov 20, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PreciControl Everolimus Elecsys and cobas e analyzers
Nov 20, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Elecsys Sirolimus Elecsys and cobas e analyzers
Nov 20, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Everolimus Elecsys and cobas e analyzers
Nov 17, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
PROBEWASH M Modular Analytics E170, cobas e 601 and cobas e 602 analyzers
Nov 16, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
Elecsys CYFRA 21-1 Elecsys and cobas e analyzers
Nov 16, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS CYFRA 21-1 CalSet Elecsys and cobas e analyzers
Nov 16, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Diluent Universal 2 Elecsys and cobas e analyzers
Nov 12, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys LH Elecsys and cobas e analyzers
Nov 11, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PHOS2 Phosphate (Inorganic) ver.2 Cobas Integra / cobas c systems
Nov 10, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
NH3L Ammonia COBAS INTEGRA / cobas c systems
Nov 10, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Anti HCV II Elecsys and cobas e analyzers
Nov 10, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
NSE CalSet Elecsys and Cobas e Analyzers
Nov 6, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS LH CalSet II Elecsys and cobas e analyzers
Nov 6, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS T-Uptake CalSet Elecsys and cobas e analyzers
Nov 6, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Vitamin B12 II Elecsys and cobas e analyzers
Nov 6, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Vitamin B12 II CalSet Elecsys and cobas e analyzers
Nov 4, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS T4 CalSet Elecsys and cobas e analyzers
Nov 2, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS T3 CalSet Elecsys and cobas e analyzers
Nov 2, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys FSH Elecsys and cobas e analyzers
Nov 2, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
PRECICONTROL Tumor Marker Elecsys and cobas e analyzers
Oct 29, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS BILD2 cobas c 111 Bilirubin Direct Gen.2
Oct 26, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS RF Control Set Roche Systems
Oct 26, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS FRA Fructosamine Cobas Integra / cobas c systems
Oct 23, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CEA CalSet Elecsys and cobas e analyzers
Oct 23, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Elecsys Anti-HBS II Elecsys and cobas e analyzers
Oct 21, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
COBAS RF-II Tina-quant Rheumatoid Factors II COBAS INTEGRA / cobas c systems
Oct 20, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
TRSF2 Tina-quant Transferrin ver.2 COBAS INTEGRA / cobas c systems
Oct 20, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS STFR Tina-quant Soluble Transferrin Receptor COBAS INTEGRA / cobas c systems
Oct 19, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CRPLX C-Reactive Protein (Latex) Cobas Integra/ cobas c system
Oct 19, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
UIBC Unsaturated Iron Binding Capacity COBAS INTEGRA / cobas c systems
Oct 16, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS h 232 and Accessories
Oct 13, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PHNY2 ONLINE TDM Phenytoin cobas c systems
Oct 13, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS 6800 Systems and Accessories
Oct 8, 2020
- Manufacturer
- ROCHE DIAGNOSTICS INTERNATIONAL, LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Elecsys Prolactin II Elecsys and cobas e analyzers
Oct 7, 2020
- Manufacturer
- ROCHE DIAGNOSTICS (SUZHOU) LTD
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Elecsys BRAHMS PCT Elecsys and cobas e analyzers
Oct 5, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COAGUCHEK Pro II Coagulation Meter and Accessories
Oct 1, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COAGUCHEK Pro II Coagulation Meter and Accessories
Oct 1, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS CKMBL Creatine Kinase-MB Cobas Integra / cobas c systems
Sep 25, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS ProBNP II CalSet Elecsys and Cobas e Analyzers
Sep 23, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Anti-TSHR Elecsys and cobas e analyzers
Sep 22, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ISE Solution 2 COBAS INTEGRA
Sep 20, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Precinorm Protein Roche Systems
Sep 20, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS MYOGLOBIN Control Set Roche Systems
Sep 20, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ISE Calibrator Indirect / Urine COBAS INTEGRA
Sep 17, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS ISE Solution 3 Cobas Integra
Sep 17, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Diluent Hepatitis A Elecsys and cobas e analyzers
Sep 16, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH., GERMANY
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS ISE Solution 1 Cobas Integra
Sep 15, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ISE Reference Electrolyte COBAS INTEGRA
Sep 15, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS ISE Etcher Cobas Integra
Sep 14, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
CLEAN Cleaner Cassette COBAS INTEGRA
Sep 14, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
ROCHE Folate RBC Hemolyzing Reagent Elecsys and cobas e analyzers
Sep 14, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ISE Calibrator Direct COBAS INTEGRA
Sep 14, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CA 15-3 II CalSet Elecsys and cobas e analyzers
Sep 14, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS ISE Deproteinizer Cobas Integra
Sep 12, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS LIPC cobas c 111 Lipase Colometric Assay
Sep 9, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS ASTLP Aspartate Aminotransferase PyP cobas c systems
Sep 9, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
AMY-P a-Amylase EPS Pancretic Cobas Integra / cobas c systems
Sep 9, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Cobas Elecsys hGH Elecsys and cobas e analyzers
Sep 9, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Precicontrol Varia Elecsys and Cobas e Analyzers
Sep 9, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS ALTLP (Alanine Aminotransferase PyP) cobas c systems
Sep 4, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS A1CD2 Hemolyzing Reagent Gen.2 cobas c systems
Sep 3, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
BILD2 Bilirubin Direct Gen.2 Cobas Integra / cobas c systems
Sep 2, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.,
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS UREAL Urea/Bun Cobas Integra cobas c systems
Aug 31, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys CA 72-4 Elecsys and cobas e analyzers
Aug 30, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Elecsys Anti-Tg Elecsys and cobas e analyzers
Aug 28, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Vitamin D total Elecsys and cobas e analyzers
Aug 28, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Diluent Estradiol / Progesterone Elecsys and cobas e analyzers
Aug 27, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ELECSYS Anti-HAV Elecsys and cobas e analyzers
Aug 26, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Elecsys CMV IgG Avidity Elecsys and cobas e analyzers
Aug 21, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
Cobas b 123 < 3 > POC System
Aug 19, 2020
- Manufacturer
- ROCHE DIAGNOSTICS INTERNATIONAL LTD
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS PreciControl Anti-HAV Elecsys and cobas e analyzers
Aug 19, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys HSV-2 IgG Elecsys and cobas e analyzers
Aug 16, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS Vitamin D Total CalSet Elecsys and cobas e analyzers
Aug 9, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PTH CalSet Elecsys and Cobas e Analyzers
Aug 7, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys HSV-1 IgG Elecsys and cobas e analyzers
Aug 4, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
ROCHE Elecsys CMV IgG Elecsys and cobas e analyzers
Jul 28, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0
Jul 24, 2020
- Manufacturer
- ROCHE MOLECULAR SYSTEMS INC.
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
COBAS Elecsys β-CrossLaps/Serum Elecsys and cobas e Analyzers
Jul 24, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS ISE Reference Electrolyte Roche/Hitachi
Jul 22, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CKMBL cobas c 111 Creatine Kinase - MB
Jul 20, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS HIV-1 Quantitative nucleic acid test for use on the COBAS 6800/8800 Systems
Jul 14, 2020
- Manufacturer
- ROCHE MOLECULAR SYSTEMS INC.
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
Combur 10 Test UX (SG, pH, LEU, NIT, PRO, GLU, KET, UBG, BIL, ERY/Hb, COMP)
Jul 10, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS ROCHE Accutrend Triglycerides
Jul 7, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
Cobas Accutrend Control G
Jul 6, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS HBV Quantitative nucleic acid test for use on the cobas 6800/8800 Systems
Jul 3, 2020
- Manufacturer
- ROCHE MOLECULAR SYSTEMS INC.
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
COBAS AmpliPrep/COBAS TaqMan CMV Test (CMVCAP)
Jul 2, 2020
- Manufacturer
- ROCHE MOLECULAR SYSTEMS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
COBAS AmpliPrep/COBAS TaqMan HCV Quantitative Test, v2.0 (HCVQTV2)
Jun 30, 2020
- Manufacturer
- ROCHE MOLECULAR SYSTEMS INC.
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
COBAS NHP Negative Control Kit Normal, non-reactive human plasma control kit for use on the cobas 6800/8800 systems
Jun 22, 2020
- Manufacturer
- ROCHE MOLECULAR SYSTEMS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
cobas Influenza A/B Quality Control Kit for use on the cobas Liat System
Jun 18, 2020
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
cobas Influenza A/B & RSV Quality Control Kit for use on the cobas Liat System
Jun 14, 2020
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Influenza A/B Nucleic acid test for use on the cobas Liat System
Jun 9, 2020
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, V2.0
May 29, 2020
- Manufacturer
- ROCHE MOLECULAR SYSTEMS INC.
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
ACCU-CHEK Guide Wireless Blood Glucose Meter Only
May 19, 2020
- Manufacturer
- SANMINA CORPORATION
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
VENTANA HE 600 Cleaning Solution
May 13, 2020
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA HE 600 Eosin
May 13, 2020
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA HE 600 Hematoxylin
May 13, 2020
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA HE 600 Transfer Fluid
May 13, 2020
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA HE 600 Bluing
May 13, 2020
- Manufacturer
- VENTANA MEDICAL SYSTEMS INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA HE 600 Wash
May 4, 2020
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS BENZ Abuscreen OnLine Benzodiazepines COBAS INTEGRA
May 2, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA HE 600 Differentiating Solution
May 1, 2020
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA HE 600 Coverslip Activator
Apr 28, 2020
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
VENTANA HE 600 Organic Solution
Apr 28, 2020
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
Elecsys AMH Plus Elecsys and cobas e analyzers
Apr 21, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys proBNP II cobas e analyzers
Apr 7, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
SMS/Acid Wash Roche / Hitachi
Apr 2, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COBAS Elecsys BRAHMS PCT cobas e analyzers
Mar 24, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PreciControl Maternal Care Elecsys and cobas e analyzers
Mar 19, 2020
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS C1 Calibration Solution 1 cobas b 121, Roche OMNI C
Mar 6, 2020
- Manufacturer
- ROCHE DIAGNOSTICS INTL, LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS C2 Calibration Solution 2 cobas b121, Roche OMNI C
Feb 21, 2020
- Manufacturer
- ROCHE DIAGNOSTICS INTL, LTD.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ACCU-CHEK Softclix Lancets
Feb 21, 2020
- Manufacturer
- ROCHE DIABETES CARE GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
ACCU-CHEK Performa and Accessories
Feb 10, 2020
- Manufacturer
- SANMINA CORPORATION.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : C
ACCU-CHEK Active Control
Feb 10, 2020
- Manufacturer
- ROCHE DIABETES CARE GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS INSTC Instrument Check cobas c systems
Dec 30, 2019
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
MDNII ONLINE DAT Methadone II Cobas Integra
Nov 22, 2019
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
THC II ONLINE DAT Cannabinoids II Cobas Integra
Nov 22, 2019
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS CRPL3 C-Reactive Protein Gen.3 cobas c systems
Nov 22, 2019
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
BENZ ONLINE DAT Benzodiazepin Plus cobas c systems
Nov 22, 2019
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PCP Abuscreen OnLine Phencyclidine Cobas Integra
Nov 11, 2019
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
OPI ONLINE DAT Opiates 300/2000 Cobas Integra
Nov 11, 2019
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
LDLC3 LDL-Cholesterol Gen.3 cobas c systems
Oct 17, 2019
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS PPX Abuscreen Online Propoxyphene Cobas Integra
Oct 17, 2019
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS MTQL ONLINE DAT Methaqualone COBAS INTEGRA
Oct 17, 2019
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ELECSYS Troponin T hs cobas e analyzer
Oct 7, 2019
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ELECSYS Troponin T hs STAT cobas e analyzer
Oct 7, 2019
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys Troponin T hs cobas e analyzers
Sep 19, 2019
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS AmpliPrep/COBAS TaqMan Wash Reagent (PG WR)
Sep 18, 2019
- Manufacturer
- ROCHE MOLECULAR SYSTEMS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COMBITROL TS+ Level 2
Sep 6, 2019
- Manufacturer
- BIONOSTICS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
VENTANA iScan Coreo and Accessories
Sep 2, 2019
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
COMBITROL TS+ Level 3
Aug 26, 2019
- Manufacturer
- BIONOSTICS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS 8000 c 701 Module and Accessories
Aug 19, 2019
- Manufacturer
- HITACHI HIGH TECHNOLOGIES CORP.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COMBITROL TS+ Level 1
Aug 19, 2019
- Manufacturer
- BIONOSTICS INC.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS 8000 e 602 Module and Accessories
Aug 19, 2019
- Manufacturer
- HITACHI HIGH TECHNOLOGIES CORP.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Elecsys HBsAg II Elecsys and cobas e analyzers
Aug 13, 2019
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 3
- Risk Class
- Kelas Resiko : D
COBAS CO2-L Bicarbonate Liquid cobas c systems
Aug 9, 2019
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS 8000 c 702 Module and Accessories
Aug 9, 2019
- Manufacturer
- HITACHI HIGH TECHNOLOGIES CORP.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS 8000 C 502 Module and Accessories
Jul 29, 2019
- Manufacturer
- HITACHI HIGH TECHNOLOGIES CORP.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
ROCHE CKL cobas c 111 Creatine Kinase
Jul 29, 2019
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 2
- Risk Class
- Kelas Resiko : B
COBAS Multiclean Roche/Hitachi
Jul 19, 2019
- Manufacturer
- ROCHE DIAGNOSTICS GMBH.
- Class
- Kelas : 1
- Risk Class
- Kelas Resiko : A
About this profile
Data sourced from Ministry of Health, Indonesia.
Last updated: September 2026