Pure Global
Home/Indonesia Database/Authorized Representative
🇮🇩

PT. SIEMENS HEALTHINEERS INDONESIA

Authorized Representative in Indonesia

Perkantoran Hijau Arkadia Tower F, Lantai 18, Jl.Tahi Bonar Simatupang Kav. 88
703 Products Represented
133 Manufacturers
Total Products
703
Manufacturers
133
Product Classes
3
Risk Classes
4
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
36 products
5.1%
Kelas Resiko : B
488 products
69.4%
Kelas Resiko : C
160 products
22.8%
Kelas Resiko : D
19 products
2.7%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (703)
Complete portfolio registered with BPOM

DIMENSION Revised C-Reactive Protein Calibrator (RCRP CAL)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 10, 2025

IMMULITE 2000 3gAllergy Specific IgE Positive Control for D1 &D2

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 10, 2025

ADVIA Centaur Calibrator D

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 10, 2025

IMMULITE 2000 Systems Allergen Specific IgE Universal Kit

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 10, 2025

DIMENSION Bilirubin Calibrator (TBI/DBI CAL)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 10, 2025

ADVIA Centaur Anti-HBs2 Quality Control (aHBs2 QC)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 10, 2025

ADVIA Centaur CA 15-3

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 10, 2025

CLINITEK Status+ Analyzer and Accessories

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 7, 2025

ADVIA Centaur Insulin (IRI)

Manufacturer:

MINARIS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 7, 2025

DIMENSION Urea Nitrogen Flex Reagent Cartridge (BUN)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2025

DIMENSION ALDL Flex Reagent Cartridge.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2025

DIMENSION CHOL Flex Reagent Cartridge.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2025

DIMENSION LA Flex Reagent Cartridge

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2025

DIMENSION Tacrolimus Calibrator

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2025

RAPIDQC Complete Level 1

Manufacturer:

BIONOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2025

DIMENSION Clinical Chemistry System Flex Reagent Cartridge URCA

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2025

IMMULITE 2000 IGF-I

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2025

ADVIA Centaur IL-6 QC

Manufacturer:

AXIS-SHIELD DIAGNOSTICS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 5, 2025

DIMENSION Glucose Flex reagent cartridge (GLUC)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 5, 2025

SYNGO Carbon Space

Manufacturer:

SIEMENS HEALTHINEERS AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 5, 2025

AI-Rad Companion Chest X-ray

Manufacturer:

SIEMENS HEALTHINEERS AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 4, 2025

DIMENSION Clinical Chemistry System FLEX Reagent Cartridge IBCT

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 3, 2025

DIMENSION Clinical Chemistry System Flex Reagent Cartridge TGL

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 3, 2025

ADVIA Centaur Multi Diluent 10 ReadyPack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2025

ADVIA Centaur Calibrator E

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.(EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2025

ADVIA 120/ ADVIA 2120/ ADVIA 2120i DIFF TIMEPAC

Manufacturer:

FISHER DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2025

ADVIA Centaur HBc IgM Quality Control (aHBcM QC)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2025

DIMENSION and Dimension Vista Lipase Calibrator

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 22, 2025

ATELLICA IM 1600 Analyzer

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 20, 2025

ADVIA Centaur Enhanced Estradiol (eE2)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.(EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 20, 2025

SIEMENS Biograph Vision Quadra

Manufacturer:

SIEMENS MEDICAL SOLUTIONS USA., INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 20, 2025

ADVIA Centaur Vitamin B12 (VB12)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 20, 2025

ADVIA Centaur FER

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.(EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 20, 2025

IMMULITE 1000 Toxoplasma IgM

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 17, 2025

ADVIA Centaur CA 125II Ready Pack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 17, 2025

DIMENSION ENZ II CAL.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 17, 2025

ADVIA Centaur CA 125II Calibrator

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 15, 2025

ADVIA Centaur T4 Ready Pack.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 14, 2025

ADVIA 120/ADVIA 2120/ADVIA 2120i CN-Free CBC TIMEPAC

Manufacturer:

Fisher Diagnostics, USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 13, 2025

DIMENSION IBCT Calibrator.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 13, 2025

ATELLICA™ IM 1300 Analyzer and Accessories

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 13, 2025

DIMENSION Ammonia Flex (AMM) Reagents

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 13, 2025

DIMENSION EXL with LM Integrated Chemistry System.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC (FLANDERS)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 13, 2025

ADVIA Centaur CP System

Manufacturer:

STRATEC SWITZERLAND AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 9, 2025

DIMENSION Total Bilirubin Flex (TBI) reagent cartridge

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 9, 2025

ATELLICA CI 1900 Analyzer and Accesories

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 9, 2025

ADVIA Centaur HBc Total 2 (HBcT2)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 8, 2025

ATELLICA NEPH 630 System and Accessories

Manufacturer:

BIT ANALYTICAL INSTRUMENTS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 8, 2025

DCA ™ Systems HbA1c Reagent Kit

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (MISHAWAKA)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 8, 2025

ADVIA Centaur XPT Immunoassay System

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 8, 2025

ADVIA Centaur CEA ReadyPack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 7, 2025

Rapidchem 744 Daily Cleaning Solution Kit

Manufacturer:

MEDICA CORPORATION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 7, 2025

RAPIDLAB 348 Bufferpack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS, MANUFACTURING LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 7, 2025

ADVIA Centaur CA 15-3 Calibrator

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 7, 2025

QUIKLYTE Integrated Multisensor Standard A

Manufacturer:

NOVA BIOMEDICAL CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 4, 2025

DIMENSION Urinary/Cerebrospinal Fluid Protein Calibrator (UCFP CAL)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 4, 2025

DCA Vantage Analyzer

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 2, 2025

IMMULITE IGF-1 Control Module

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2024

DIMENSION C3 Flex Reagent Cartridge.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2024

Dimension Alkaline Phosphatase Flex reagent cartridge

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 24, 2024

AI-Rad Companion Organs RT

Manufacturer:

SIEMENS HEALTHINEERS AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 23, 2024

DIMENSION Ethyl Alcohol Flex® reagent cartridge

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC., (DELAWARE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 23, 2024

SIEMENS Sensis Vibe

Manufacturer:

SIEMENS HEALTHINEERS AG, ADVANCED THERAPIES

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 22, 2024

RAPIDLab 348EX Blood Gas Analyzer and Acessories

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 22, 2024

AI-RAD Companion Cardiovascular

Manufacturer:

SIEMENS HEALTHINEERS AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 22, 2024

AI-RAD Companion Pulmonary

Manufacturer:

SIEMENS HEALTHINEERS AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 20, 2024

CIOS Flow

Manufacturer:

SIEMENS HEALTHINEERS AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 19, 2024

CIOS Select

Manufacturer:

SIEMENS SHANGHAI MEDICAL EQUIPMENT, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 19, 2024

RAPIDPoint 500 System Analyzer and Accessories

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 19, 2024

SYNGO CARBON Enterprise Access

Manufacturer:

SIEMENS HEALTHINEERS AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 17, 2024

ARTIS Zee Floor

Manufacturer:

SIEMENS HEALTHINEERS AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 17, 2024

MOBILETT Elara Max

Manufacturer:

SOCIEDAD ESPANOLA DE ELECTROMEDICINA Y CALIDAD, S.A. (SEDECAL).

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 13, 2024

MAGNETOM Free.Max

Manufacturer:

SIEMENS HEALTHINEERS AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 13, 2024

SOMATOM Scope

Manufacturer:

SIEMENS HEALTHINEERS AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 12, 2024

MAMMOMAT Revelation

Manufacturer:

SIEMENS HEALTHINEERS AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 12, 2024

MULTIX Impact

Manufacturer:

SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 12, 2024

SOMATOM X.cite

Manufacturer:

SIEMENS HEALTHINEERS AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 12, 2024

DIMENSION Lactate Dehydrogenase Flex reagent cartridge (LDI)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 11, 2024

DIMENSION Direct Bilirubin Flex reagent cartridge (DBI Flex)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 11, 2024

MAGNETOM Sola

Manufacturer:

SIEMENS HEALTHINEERS AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 9, 2024

ARTIS Icono Ceiling

Manufacturer:

SIEMENS HEALTHINEERS, AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 9, 2024

SOMATOM X.ceed

Manufacturer:

SIEMENS HEALTHINEERS AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 9, 2024

AI-RAD Companion Prostate MR

Manufacturer:

SIEMENS HEALTHINEERS AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 5, 2024

MAGNETOM Altea

Manufacturer:

SIEMENS SHENZHEN MAGNETIC RESONANCE LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 5, 2024

AI-RAD Companion Musculoskeletal

Manufacturer:

SIEMENS HEALTHINEERS AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 5, 2024

MAGNETOM Avanto Fit

Manufacturer:

SIEMENS HEALTHINEERS AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 5, 2024

MAGNETOM Sola

Manufacturer:

SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. (SSMR)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 5, 2024

SYNGO. PLAZA

Manufacturer:

SIEMENS HEALTHCARE GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 2, 2024

SOMATOM Force

Manufacturer:

SIEMENS HEALTHINEERS AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 2, 2024

SOMATOM go. Open Pro

Manufacturer:

SIEMENS HEALTHINEERS AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 2, 2024

SOMATOM go. Sim

Manufacturer:

SIEMENS HEALTHINEERS AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 2, 2024

POLYMOBIL Plus

Manufacturer:

SOCIEDAD ESPANOLA DE ELECTROMEDICINA Y CALIDAD, S.A. (SEDECAL)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 26, 2024

SOMATOM go. Top

Manufacturer:

SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 26, 2024

ARTIS Icono Biplane

Manufacturer:

SIEMENS HEALTHINEERS AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 26, 2024

SOMATOM Drive

Manufacturer:

SIEMENS HEALTHINEERS AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 25, 2024

IMMULITE EPO CONTROL MODULE

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 18, 2024

MAGNETOM Free.Max

Manufacturer:

SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 15, 2024

MAGNETOM Altea

Manufacturer:

SIEMENS HEALTHINEERS AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 15, 2024

MAMMOMAT Inspiration

Manufacturer:

SIEMENS HEALTHINEERS AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 14, 2024

ATELLICA VTLi Immunoassay Analyzer

Manufacturer:

LRE MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 9, 2024

MAMMOMAT B.brilliant

Manufacturer:

SIEMENS HEALTHINEERS AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 20, 2024

SIEMENS N Antiserum to Human Fibrinogen

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 20, 2024

SIEMENS N Sample Diluent

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 12, 2024

SIEMENS N/T Protein Control SL/L

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 11, 2024

SIEMENS N/T N Latex Ferritin

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 11, 2024

SIEMENS CIOS Fusion Mobile Radiography System

Manufacturer:

Siemens Healthineers AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 2, 2024

SamaTom Emotion 16

Manufacturer:

SIEMENS HEALTHINEERS AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 2, 2024

Syngo Carbon Clinicals

Manufacturer:

SIEMENS HEALTHINEERS AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 26, 2024

SOMATOM Confidence

Manufacturer:

SIEMENS HEALTHINEERS AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 22, 2024

LUMINOS dRF Max

Manufacturer:

SIEMENS HEALTHINEERS, AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 12, 2024

SOMATOM Edge Plus

Manufacturer:

Siemens Healthineers AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 12, 2024

SIEMENS Cios Connect

Manufacturer:

SIEMENS HEALTHINEERS AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 7, 2024

SIEMENS Biograph mMR

Manufacturer:

SIEMENS HEALTHINEERS, AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 4, 2024

Sensis Vibe Hemo

Manufacturer:

SIEMENS HEALTHINEERS AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2024

MAGNETOM Verio

Manufacturer:

SIEMENS HEALTHINEERS AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 10, 2024

MAGNETOM Aera

Manufacturer:

SIEMENS HEALTHINEERS AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 8, 2024

MAGNETOM Avanto

Manufacturer:

SIEMENS HEALTHINEERS AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 8, 2024

Magnetom Skyra

Manufacturer:

SIEMENS HEALTHINEERS AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 8, 2024

ACUSON Maple Diagnostic Ultrasound System

Manufacturer:

SIEMENS HEALTHCARE S.R.O

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 29, 2024

SIEMENS Acuson Origin

Manufacturer:

SIEMENS MEDICAL SOLUTIONS USA, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 21, 2024

ACUSON Maple Select

Manufacturer:

SIEMENS HEALTHCARE S.R.O

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 18, 2024

MULTITOM RAX

Manufacturer:

SIEMENS HEALTHINEERS AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 14, 2024

UROSKOP Omnia Max

Manufacturer:

SIEMENS HEALTHINEERS, AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 14, 2024

URILYZER Cell Analyzer

Manufacturer:

77 ELECTRONICS INSTRUMENTATION Ltd

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 22, 2024

YSIO X.pree

Manufacturer:

SIEMENS HEALTHINEERS AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 22, 2024

SYMBIA Pro.specta X7

Manufacturer:

SIEMENS MEDICAL SOLUTIONS USA., INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 31, 2024

SYMBIA Pro.specta X3

Manufacturer:

SIEMENS MEDICAL SOLUTIONS USA., INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 31, 2024

SIEMENS N FLC Control SL

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2024

MULTIX Impact E

Manufacturer:

SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 8, 2024

Magnetom Sempra Elite

Manufacturer:

SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 29, 2023

SIEMENS N Antiserum to Human Transferrin

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 28, 2023

SIEMENS N Protein Standard UY

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH .

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 28, 2023

SIEMENS Cleaner SCS

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH .

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 28, 2023

SIEMENS N Latex RF Kit

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 27, 2023

EMIT II Plus 6-AM/Ecstasy Calibrator/Control Level 4

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 22, 2023

EMIT® II Plus 6-AM/Ecstasy Calibrator/Control Level 1

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC., USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 22, 2023

SYMBIA PRO. SPECTA Q3

Manufacturer:

SIEMENS MEDICAL SOLUTIONS USA., INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 21, 2023

MOBILETT Impact Digital Mobile X-ray System

Manufacturer:

SOCIEDAD ESPANOLA DE ELECTROMEDICINA Y CALIDAD, S.A. (SEDECAL)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 21, 2023

VIVA-ProE System and Accessories

Manufacturer:

ELITECHGROUP B.V.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 17, 2023

IMMULITE 2000 Immunoassay System

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 13, 2023

TRANSPORT

Manufacturer:

SCREENPOINT MEDICAL B.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 19, 2023

ACUSON NX3

Manufacturer:

SIEMENS HEALTHCARE S.R.O

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 19, 2023

ACUSON SC2000 Ultrasound System

Manufacturer:

SIEMENS MEDICAL SOLUTIONS USA, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 17, 2023

ACUSON P500 Diagnostic Ultrasound System

Manufacturer:

SIEMENS HEALTHCARE S.R.O

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 17, 2023

IMMULITE 2000 EPO

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 11, 2023

DIMENSION Immunoglobulin A (IgA)Flex reagent cartridge

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 11, 2023

CIOS Select

Manufacturer:

SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD. (SSME)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 3, 2023

ADVIA Centaur Squamous Cell Carcinoma Calibrator (SCC CAL)

Manufacturer:

FUJIREBIO EUROPE N.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 26, 2023

ATELLICA IM Squamous Cell Carcinoma Calibrator (SCC CAL)

Manufacturer:

FUJIREBIO EUROPE N.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 25, 2023

ADVIA Chemistry CRP_2 Calibrators

Manufacturer:

RANDOX LABORATORIES LTD,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 25, 2023

ATELLICA IM Squamous Cell Carcinoma (SCC)

Manufacturer:

FUJIREBIO EUROPE N.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 25, 2023

ATELLICA IM HBc Total 2 Quality Control (HBcT2 QC)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 20, 2023

ATELLICA IM Ancillary Probe Wash 3

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. USA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 17, 2023

ADVIA Centaur Squamous Cell Carcinoma (SCC)

Manufacturer:

FUJIREBIO EUROPE N.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 14, 2023

ADVIA Centaur HBsAg Quality Control

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 13, 2023

RAPID QC PLUS LEVEL 1

Manufacturer:

BIONOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 11, 2023

ACUSON Juniper Diagnostic Ultrasound System

Manufacturer:

SIEMENS HEALTHCARE S.R.O

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 7, 2023

Atellica CH Albumin BCP (AlbP)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 6, 2023

ATELLICA IM Intact Parathyroid Hormone (PTH)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 6, 2023

ACUSON Juniper Select Diagnostic Ultrasond System

Manufacturer:

SIEMENS HEALTHCARE S.R.O

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 6, 2023

SIEMENS RAPID QC HCT LEVEL A

Manufacturer:

BIONOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 4, 2023

Multix Impact C

Manufacturer:

SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 27, 2023

MULTIX Select DR X-ray System

Manufacturer:

SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 23, 2023

SOMATOM X.ceed

Manufacturer:

SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 23, 2023

Mammomat Select.

Manufacturer:

SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 23, 2023

SOMATOM go. Sim

Manufacturer:

SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 20, 2023

SOMATOM go. Open Pro

Manufacturer:

SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 19, 2023

ADVIA Chemistry Enzymatic Creatinine_3 (ECre3)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 19, 2023

SOMATOM go. Up

Manufacturer:

SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 19, 2023

Atellica Rack Handler

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.,

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 17, 2023

MULTIX Fusion Max

Manufacturer:

SIEMENS HEALTHCARE GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 16, 2023

SOMATOM go. All

Manufacturer:

SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD. (SSME)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 16, 2023

EUROTROL epoc GAS-ISE Metabolites – Level 3

Manufacturer:

EUROTROL B.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 16, 2023

SOMATOM go. Now

Manufacturer:

SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD. (SSME)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 16, 2023

ADVIA Centaur Calibrator A

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 25, 2023

ADVIA Centaur BR Pretreatment Reagent

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 25, 2023

ACUSON X600

Manufacturer:

SIEMENS HEALTHINEERS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 24, 2023

ADVIA Centaur Calibrator G

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 22, 2023

Atellica IM Base

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. USA (NEWARK)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 20, 2023

Atellica IM Acid

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. USA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 20, 2023

Atellica IM anti-HB2 (aHBe2)

Manufacturer:

BIOKIT S.A

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 19, 2023

ADVIA Centaur anti-HB2 (aHBe2)

Manufacturer:

BIOKIT, S.A.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 19, 2023

IMMULITE D-Dimer Control Module

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 16, 2023

Atellica® HEMA 580 Analyzer (SMS ready)

Manufacturer:

HORIBA ABX SAS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 16, 2023

Atellica CH Lactate_2 (Lac_2)

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 10, 2023

Atellica CH Pancreatic Amylase_2 (PAMY_2)

Manufacturer:

RANDOX LABORATORIES LTD.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 10, 2023

ADVIA 2120i Hematology System and Accessories

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 10, 2023

Atellica IM anti-HB2 Quality Control (aHBe2 QC)

Manufacturer:

BIOKIT S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 5, 2023

FTD Viral meningitis

Manufacturer:

FAST TRACK DIAGNOSTICS LUXEMBOURG S.A R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 4, 2023

ADVIA Centaur Tumor Marker Quality Control (TM QC)

Manufacturer:

FUJIREBIO EUROPE N.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 30, 2023

CellaVision DM1200

Manufacturer:

CELLAVISION AB

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 28, 2023

ATELLICA IM Tumor Marker Quality Control (TM QC)

Manufacturer:

FUJIREBIO EUROPE N.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 28, 2023

SYMBIA T6 SPECT/CT System

Manufacturer:

SIEMENS MEDICAL SOLUTIONS USA., INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 28, 2023

ADVIA Centaur anti-HB2 Quality Control (aHBe2 QC)

Manufacturer:

BIOKIT, S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 28, 2023

IMMULITE 2000 Rubella Quantitative IgG

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 20, 2023

IMMULITE 2000 Toxoplasma IgM (µ-Capture)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 20, 2023

IMMULITE 2000 CMV IgG

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 20, 2023

IMMULITE 2000 Rubella IgM

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 20, 2023

IMMULITE 2000 Toxoplasma Quantitative IgG

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 20, 2023

MAGNETOM Symphony A Tim System

Manufacturer:

SIEMENS HEALTHCARE GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 22, 2023

ADVIA Centaur Herpes-2 IgG (HSV2) QC

Manufacturer:

BIOKIT, S.A. BARCELONA, SPAIN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 10, 2023

Chek-Stix UA Diptube Liquid QC

Manufacturer:

KOVA INTERNATIONAL, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 10, 2023

ADVIA Centaur Herpes-1 IgG (HSV1)

Manufacturer:

BIOKIT, S.A. SPAIN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 10, 2023

ADVIA Centaur Herpes-1 IgG (HSV1) QC

Manufacturer:

BIOKIT, S.A. BARCELONA, SPAIN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 10, 2023

EMIT Calibrator / Control Level 3

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC., USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 7, 2023

Chek-Stix Liquid QC Kit + Sediment

Manufacturer:

KOVA INTERNATIONAL, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 7, 2023

Luminous Fusion

Manufacturer:

SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 6, 2023

Emit Calibrator / Control Level 4

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC., USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 6, 2023

ADVIA Centaur BNP

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 22, 2023

ADVIA Centaur HBeAg

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.(EAST WALPOLE)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 22, 2023

ADVIA Centaur™ HBeAg Quality Control (QC)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 20, 2023

Emit 2000 Valproic Acid Calibrators

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC., USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 7, 2023

Emit II Plus Cannabinoid Assay

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 7, 2023

EMIT II Plus Barbiturate Assay

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2023

EMIT II Plus Amphetamines Assay

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2023

Emit II Plus Benzodiazepine Assay

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC., USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2023

Emit Ethyl Alcohol Negative Calibrator

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC., USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 2, 2023

EMIT Calibrator/Control Level 5

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC., USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 2, 2023

Syva Emit Calibrator / Control Level 0 (negative)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC., USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

SYVA Emit II Plus 6-AM/Ecstasy Calibrator/Control Level 3

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

ATELLICA HEMA Control (L)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

SYVA Emit II Plus Propoxyphene Assay

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC., USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

Syva Emit II Plus Cocaine Metabolite Assay

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC., USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

Emit II Plus Ethyl Alcohol Assay

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC., USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

SYVA Emit Ethyl Alcohol High Control

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

Emit 2000 Valproic Acid Assay

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC., USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

Atellica HEMA Control (H)

Manufacturer:

R&D SYSTEM

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

ADVIA Autoslide Slide Maker Stainer (SMS)

Manufacturer:

HORIBA ABX SAS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

SYVA Emit Calibrator / Control Level 2

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

Syva Emit Calibrator / Control Level 1

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC., USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

SYVA Emit II Plus Opiate Assay

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC., USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

ACUSON NX3 Elite

Manufacturer:

SIEMENS HEALTHINEERS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 29, 2022

ACUSON X150 Ultrasound System

Manufacturer:

SIEMENS HEALTHINEERS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 29, 2022

ACUSON Redwood

Manufacturer:

SIEMENS HEALTHINEERS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 29, 2022

Dimension Urine Barbiturate Screen Flex reagent cartridge

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2022

ACUSON P500

Manufacturer:

SIEMENS HEALTHINEERS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2022

ACUSON Juniper

Manufacturer:

SIEMENS HEALTHINEERS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2022

Atellica HEMA Slidemaker Stainer (SMS)

Manufacturer:

HORIBA ABX SAS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2022

DIMENSION Urine Amphetamine/Methamphetamine Screen Flex reagent cartridge

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 27, 2022

ACUSON X300

Manufacturer:

SIEMENS HEALTHINEERS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2022

ACUSON NX2 Elite Diagnostic Ultrasound System

Manufacturer:

SIEMENS HEALTHINEERS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2022

ACUSON NX3

Manufacturer:

SIEMENS HEALTHINEERS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2022

EPOC Reader Blood Analysis

Manufacturer:

EPOCAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 14, 2022

AI-RAD Companion Brain MR

Manufacturer:

SIEMENS HEALTHCARE GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 12, 2022

HEMATEK 3000 System and Accessories

Manufacturer:

BIT ANALYTICAL INSTRUMENTS GMBH,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 8, 2022

ADVIA Chemistry ALP_2c (Alkaline Phosphatase_2 Concentrated Reagents)

Manufacturer:

RANDOX LABORATORIES, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 6, 2022

ADVIA Centaur AMH Quality Control (AMH QC)

Manufacturer:

. SIEMENS HEALTHCARE DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 5, 2022

SYMBIA Intevo Excel

Manufacturer:

SIEMENS MEDICAL SOLUTIONS USA., INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 5, 2022

ATELLICA HEMA Control Body Fluid_BF (H)

Manufacturer:

R&D SYSTEMS, INC. USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 5, 2022

ADVIA Chemistry Creatinine Reagents

Manufacturer:

RANDOX LABORATORIES LTD.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 30, 2022

ADVIA Centaur Anti Mullerian Hormone (AMH)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 25, 2022

ADVIA Chemistry Urea Nitrogen Reagents (UN)

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 25, 2022

ATELLICA IM Cortisol Urine Reconstitution Buffer

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 25, 2022

ATELLICA IM Anti Mullerian Hormone (AMH)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 25, 2022

CLINAC CX

Manufacturer:

VARIAN MEDICAL SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 25, 2022

IMMULITE 2000 Systems High Sensitivity CRP

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 25, 2022

IMMULITE 2000 / IMMULITE 2500 Probe Cleaning Kit

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 23, 2022

RAPIDChem 744 Analyzer

Manufacturer:

MEDICA CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 18, 2022

ATELLICA HEMA Control (N)

Manufacturer:

R&D SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 16, 2022

Clinitek Microalbumin 2

Manufacturer:

KIMBALL ELECTRONICS POLAND SP. Z.O.O.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 16, 2022

Atellica Urinalysis Sediment 800 (UAS 800) Analyzer

Manufacturer:

77 ELECTRONICS INSTRUMENTATION Ltd

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 14, 2022

N AS IgG 1

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 9, 2022

IMMULITE 2000 Systems Osteocalcin

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 9, 2022

Biograph Vision 450 Edge

Manufacturer:

SIEMENS MEDICAL SOLUTIONS USA., INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 8, 2022

ATELLICA HEMA Control Body Fluid_BF

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 7, 2022

Acuson NX2

Manufacturer:

SIEMENS HEALTHINEERS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2022

ADVIA Centaur Multi-Diluent 3 Ready Pack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2022

CLINITEK Advantus Analyzer and Accessories..

Manufacturer:

KIMBALL ELECTRONICS POLAND SP. Z.O.O.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2022

BIOGRAPH Horizon

Manufacturer:

SIEMENS MEDICAL SOLUTIONS USA, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 24, 2022

ADVIA Centaur CKMB Diluent

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 24, 2022

ADVIA Centaur DIL Multi-Diluent 12

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 24, 2022

Symbia Intevo Bold

Manufacturer:

SIEMENS MEDICAL SOLUTIONS USA., INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 24, 2022

Atellica HEMA RETIC Control

Manufacturer:

R & D SYSTEM, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 21, 2022

SYMBIA Intevo 2

Manufacturer:

SIEMENS MEDICAL SOLUTIONS USA., INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 20, 2022

ADVIA Centaur PW 3

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.,

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 20, 2022

Symbia Intevo 6

Manufacturer:

SIEMENS MEDICAL SOLUTIONS USA., INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 20, 2022

Symbia Evo

Manufacturer:

SIEMENS MEDICAL SOLUTIONS USA., INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 19, 2022

ATELLICA IM BRAHMS Procalcitonin (PCT)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 19, 2022

BIOGRAPH Vision 600

Manufacturer:

SIEMENS MEDICAL SOLUTIONS USA., INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 18, 2022

BIOGRAPH Vision 600 Edge

Manufacturer:

SIEMENS MEDICAL SOLUTIONS USA., INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 18, 2022

SYMBIA Evo Excel

Manufacturer:

SIEMENS MEDICAL SOLUTIONS USA, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 18, 2022

BIOGRAPH mCT S

Manufacturer:

SIEMENS MEDICAL SOLUTIONS USA, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 18, 2022

ADVIA Centaur Ancillary Probe Wash 1 Ready Pack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 15, 2022

CLINITEK Novus Automated Urine Chemistry Analyzer

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 15, 2022

ADVIA Chemistry Gluo Glucose Oxidase Reagents

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 13, 2022

BIOGRAPH mCT X

Manufacturer:

SIEMENS MEDICAL SOLUTIONS USA, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 11, 2022

BIOGRAPH Vision 450

Manufacturer:

SIEMENS MEDICAL SOLUTIONS USA., INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 11, 2022

ADVIA 120/ADVIA 2120/ADVIA 2120i DEFOAMER.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 3, 2022

ADVIA 120/ADVIA 2120/ADVIA 2120i PEROX SHEATH.

Manufacturer:

FISHER DIAGNOSTICS

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 3, 2022

Atellica IM CMV IgM Quality Control (CMV IgM QC)

Manufacturer:

SIEMENS HEALTHCARE USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 27, 2022

DCA Vantage Analyzer

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 26, 2022

IMMULITE ACTH Control Module

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 26, 2022

ATELLICA IM Multi-Diluent 1

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 26, 2022

ADVIA Chemistry Gamma-Glutamyl Transferase (GGT) Reagents

Manufacturer:

RANDOX LABORATORIES, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 26, 2022

EPOC Hematocrit Verification Fluids

Manufacturer:

EUROTROL B. V

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 25, 2022

VERSANT HCV Genotype 2.0 Assay (LiPA)

Manufacturer:

FUJIREBIO N. V.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 23, 2022

ATELLICA CH Revised C-Reactive Protein Calibrator (RCRP Cal)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (DELAWARE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 21, 2022

Atellica CH Revised C-Reactive Protein (RCRP)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 21, 2022

ADVIA Chemistry Lactate Reagents (LAC)

Manufacturer:

RANDOX LABORATORIES LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 20, 2022

Quiklyte Dilution Check

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 20, 2022

ADVIA 120/ADVIA 2120/ADVIA 2120i auto Retic.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 19, 2022

Atellica HEMA Calibrator

Manufacturer:

R&D SYSTEMS, INC. USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 19, 2022

SIEMENS N FLC Control SL2

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 19, 2022

Atellica CH Enzymatic Creatinine_3 (ECre3)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 16, 2022

ADVIA 120/ADVIA 2120/ADVIA 2120i Sheath Rinse.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 16, 2022

IMMULITE 1000 EPO

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 16, 2022

ATELLICA CH Iron3 (Iron3)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 16, 2022

IMMULITE 1000 system F4 Free T4

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 16, 2022

FTD SARS-CoV-2

Manufacturer:

FAST TRACK DIAGNOSTICS LUXEMBOURG S.à.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 12, 2022

IMMULITE Free Beta HCG Control Module (FBC)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 12, 2022

Atellica® HEMA Decon

Manufacturer:

HORIBA ABX SAS, FRANCE

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 7, 2022

RAPIDChem 700 Urine Diluent Solution

Manufacturer:

MEDICA CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 1, 2022

IMMULITE 2000 Multi-Diluent 1

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 1, 2022

MULTIX Impact C

Manufacturer:

SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 31, 2022

IMMULITE 2000 Insulin

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2022

DCA ™ Systems HbA1c Reagent Kit

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (MISHAWAKA)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2022

EPOC Reader AP Blood Analysis

Manufacturer:

EPOCAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2022

ATELLICA HEMA HGB

Manufacturer:

HORIBA ABX SAS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 22, 2022

ATELLICA HEMA Baso

Manufacturer:

HORIBA ABX SAS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 22, 2022

ADVIA Centaur HIV Ag/Ab Combo (CHIV)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE) UNTUK SIEMENS HEALTHCARE DIAGNOSTICS INC. (TARRYTOWN)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 18, 2022

RAPIDLAB 1200 System Reagent Cartridge

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 16, 2022

ATELLICA HEMA Diluent

Manufacturer:

HORIBA ABX SAS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 16, 2022

ATELLICA® HEMA 570 Analyzer (SMS Ready)

Manufacturer:

HORIBA ABX SAS, FRANCE UNTUK SIEMENS HEALTHCARE DIAGNOSTICS INC., TARRYTOWN, USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 15, 2022

VERSACELL X3 Solution system and accesories

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 11, 2022

SIEMENS N/T Rheumatology Control SL/1

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 11, 2022

RAPIDQC Complete Level 3

Manufacturer:

BIONOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 11, 2022

IMMULITE /IMMULITE 1000 Estradiol

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 27, 2022

DIMENSION Tacrolimus Flex reagent cartridge

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 27, 2022

DIMENSION Mass Creatine Kinase MB Isoenzyme Calibrator (MMB)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 27, 2022

IMMULITE 2000 IgG/IgM Sample Diluent

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 27, 2022

DIMENSION Urinary Cerebrospinal Fluid Protein Flex reagent cartridge (UFCP)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 18, 2022

EPOC BGEM Test Cards

Manufacturer:

EPOCAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 14, 2022

Atellica® HEMA RETPLTO

Manufacturer:

HORIBA ABX SAS.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 11, 2022

Atellica® HEMA Cleaner

Manufacturer:

HORIBA ABX SAS

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 11, 2022

DIMENSION Creatine Kinase Flex (CKI ) reagent cartridge

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 7, 2022

Atellica HEMA 570_Analyzer

Manufacturer:

HORIBA ABX SAS,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 7, 2022

ATELLICA HEMA 580 Analyzer (Non SMS) and Accessories

Manufacturer:

HORIBA ABX SAS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 7, 2022

ATELLICA™ IM Hepatitis B surface Antigen II Confirmatory (HbsII Conf).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC., EAST WALPOLE, USA

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 30, 2022

ADVIA Centaur HBsAgII (HBsII)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 30, 2022

Dimension Chemistry Wash RD701

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH..

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 21, 2022

ADVIA Chemistry XPT System Analyzer

Manufacturer:

JEOL LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 13, 2022

ADVIA Centaur aHBs2 ReadyPack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC., EAST WALPOLE

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 10, 2022

DIMENSION Clinical Chemistry System Enzyme Verifier

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 10, 2022

ADVIA Centaur CMV IgM Quality Control (CMV IgM QC)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC., WALPOLE, USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 8, 2022

BN ProSpec System and Accessories

Manufacturer:

BIT ANALYTICAL INSTRUMENTS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2022

DIMENSION Cyclosporine Calibrator (CSA CAL)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 3, 2022

DIMENSION Iron Calibrator

Manufacturer:

FISHER DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 3, 2022

ADVIA Chemistry Lipoprotein(a) Reagents (LPA)

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 3, 2022

ADVIA Chemistry Direct HDL Cholesterol Reagents (D-HDL)

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 31, 2022

DIMENSION EXL™ LOCI Module LOCI Anemia Calibrator

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 31, 2022

DIMENSION EXL LOCI Module LOCI FOLA Flex reagent cartridge

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 31, 2022

VERSANT HCV Amplification 2.0 Kit (LiPA)

Manufacturer:

FUJIREBIO N. V.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 30, 2022

RAPIDChem 754 Analyzer

Manufacturer:

MEDICA CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 25, 2022

DIMENSION Enzyme I Calibrator (ENZ I CAL)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 22, 2022

ADVIA Chemistry Lipoprotein(a) Calibrator (LPA CAL)

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 22, 2022

DCA Systems Hemoglobin A1c Control Kit

Manufacturer:

CANTERBURY SCIENTIFIC LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 22, 2022

EUROTROL epoc GAS-ISE Metabolites – Level 1

Manufacturer:

EUROTROL B. V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 22, 2022

IMMULITE 2000 PEP C-Peptide

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 22, 2022

ADVIA 360/560 Calibrator

Manufacturer:

R&D SYSTEMS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 22, 2022

ADVIA Centaur SARS-CoV-2 Antigen (CoV2Ag) ReadyPack (CLIA)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 18, 2022

ADVIA Centaur NT-proBNP

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 17, 2022

ADVIA Centaur Probe Wash 4

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 17, 2022

ADVIA Centaur SARS-CoV-2 Antigen Calibrator (CoV2Ag CAL)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 16, 2022

ADVIA Centaur SARS-CoV-2 Antigen Quality Control (CoV2Ag QC)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 16, 2022

DIMENSION Chemistry I Calibrator (CHEM I CAL)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 16, 2022

ADVIA 360 Control

Manufacturer:

R&D SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 11, 2022

ADVIA Centaur TSH3-Ultra (TSH3-UL)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 11, 2022

EUROTROL EPOC GAS-ISE Metabolites Level 2

Manufacturer:

EUROTROL B.V..

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 11, 2022

ADVIA 360/560 Hypoclean CC

Manufacturer:

DIATRON MI PLC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 10, 2022

ADVIA 360/560 Diluent (Dil)

Manufacturer:

DIATRON MI PLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 28, 2022

Advia Centaur TnI-Ultra

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 27, 2022

ADVIA Centaur Cortisol (COR)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 27, 2022

IMMULITE /IMMULITE 1000 Systems IGF - I

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 25, 2022

ADVIA Centaur SARS-CoV-2 IgG (sCOVG) Ready Pack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 25, 2022

Mobius 3D

Manufacturer:

VARIAN MEDICAL SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 24, 2022

ADVIA 360 Hematology System and Accessories

Manufacturer:

DIATRON MI PLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 23, 2022

VERSANT HCV Control 2.0 Kit (LiPA)

Manufacturer:

FUJIREBIO N. V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 19, 2022

ATELLICA IM Total hCG (ThCG).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 14, 2022

ADVIA Chemistry CO2 Calibrator/Diluent.

Manufacturer:

FISHER DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 14, 2022

IMMULITE 2000 Thyroglobulin Sample Diluent

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 14, 2022

ADVIA Centaur ELF Calibrator

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC., (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 14, 2022

ADVIA Centaur C-Peptide Calibrator

Manufacturer:

MINARIS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 14, 2022

ADVIA Centaur LH

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 13, 2022

ADVIA Chemistry Apolipoprotein A1/B Calibrators (APO A1/B CAL)

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 13, 2022

ADVIA Centaur SARS-CoV-2 IgG Quality Control (sCOVG QC)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 13, 2022

ADVIA Centaur Rubella G Quality Control Material

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 12, 2022

ADVIA Centaur AFP

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 12, 2022

ADVIA Chemistry ISE Serum Standard

Manufacturer:

JEOL LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 11, 2022

ATELLICA IM Total Triiodothyronine(T3)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 11, 2022

ADVIA Centaur HA

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 11, 2022

ADVIA Chemistry Transferrin Reagents (TRF)

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 8, 2022

ADVIA Centaur C-peptide (CpS)

Manufacturer:

MINARIS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 8, 2022

DIMENSION CKI/MBI Calibrator

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 8, 2022

ADVIA Chemistry Immunoglobulin G_2 Reagents (IGG_2)

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 8, 2022

ADVIA Chemistry Immunoglobulin A_2 Reagents (IGA_2)

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2022

ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein Reagents (hsCRP)

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2022

ADVIA Centaur PIIINP

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2022

ADVIA Centaur High-Sensitivity Troponin I (TNIH)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2022

IMMULITE 1000 FSH

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2022

ATELLICA™ IM Hepatitis B surface Antigen II (HBsII)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 2, 2022

Dimension Sample Probe Cleaner

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 1, 2022

CLINITEK Novus™ Calibrator Kit

Manufacturer:

FISCHER DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 1, 2022

DIMENSION Sample Diluent

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 31, 2022

Atellica CH Total Protein_2 (TP_2)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 31, 2022

Dimension C-Reactive Protein Calibrator (CRP CAL)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 31, 2022

ADVIA Centaur Rub M

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 31, 2022

ADVIA Centaur Calibrator B

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 31, 2022

ATELLICA IM ThCG Diluent

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 31, 2022

EPOC Host Blood Analysis (EPOC Host 2) and Accessories

Manufacturer:

EPOCAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 30, 2022

Atellica CH LDL Cholesterol Calibrator (LDLC Cal)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 30, 2022

SENTINEL Pancreatic Amylase

Manufacturer:

SENTINEL CH. SPA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 29, 2022

Atellica CH Lactate_3

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 29, 2022

ATELLICA ™ IM Anti-Hepatitis B core Total (HBcT)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 25, 2022

ATELLICA CH Triglycerides_2 (Trig_2)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 25, 2022

ATELLICA CH HDL Cholesterol (HDLC)

Manufacturer:

SEKISUI DIAGNOSTICS P.E.I. INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 25, 2022

ATELLICA CH LDLC

Manufacturer:

SEKISUI DIAGNOSTICS P.E.I. INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 25, 2022

ADVIA 120/ADVIA 2120/ADVIA 2120i 3in1 TESTpoint™ Hematology Controls.

Manufacturer:

DASH INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 22, 2022

Atellica IM Total IgE Diluent (tIgE DIL)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 17, 2022

DIMENSION Clinical Chemistry System Flex Reagent Cartridge CSAE

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 16, 2022

IMMULITE 2000 TG Thyroglobulin

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 16, 2022

RP500 MEASUREMENT CARTRIDGE LAC

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 16, 2022

ADVIA 360/560 Hypoclean (Tubing)

Manufacturer:

DIATRON MI PLC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 14, 2022

Dimension IMT Probe Cleaner RD704

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 9, 2022

ADVIA Chemistry Lactate Dehydrogenase P-L (LDPL) Reagents

Manufacturer:

RANDOX LABORATORIES, LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 9, 2022

Atellica IM Total Thyroxine Diluent (T4 DIL)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 9, 2022

Atellica IM Total Thyroxine (T4)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 9, 2022

ADVIA Chemistry Liquid Specific Protein Calibrator (LSP CAL )

Manufacturer:

RANDOX LABORATORIES LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 9, 2022

ADVIA Chemistry CardioPhase hsCRP Calibrator

Manufacturer:

RANDOX LABORATORIES LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 9, 2022

ADVIA Centaur Rub M QC

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 8, 2022

ADVIA Chemistry Enzymatic Hemoglobin A1c_E Assay

Manufacturer:

SEKISUI MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 8, 2022

ADVIA Chemistry Apolipoprotein B (APO B) Reagents

Manufacturer:

RANDOX LABORATORIES LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 8, 2022

ATELLICA IM Total IgE (tIgE)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 8, 2022

ADVIA Centaur RbGII Quality Control (RbGII QC)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 8, 2022

ADVIA Chemistry Aspartate Aminotransferase (AST) Reagents

Manufacturer:

RANDOX LABORATORIES LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 8, 2022

ADVIA Chemistry Rheumatoid Factor (RF) Reagents

Manufacturer:

RANDOX LABORATORIES LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 25, 2022

Dimension Reagent Probe Cleaner

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS, INC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 25, 2022

ATELLICA IM Rubella IgG (Rub G)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 25, 2022

IMMULITE 1000 Systems TIE Total IgE

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 24, 2022

ADVIA CENTAUR FT4

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 23, 2022

ATELLICA IM Syphilis Quality Control (Syph QC)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 23, 2022

ATELLICA IM Rubella IgM (Rub M)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 23, 2022

IMMULITE 1000 Systems C-Peptide

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 22, 2022

ADVIA Centaur Toxoplasma M Quality Control (Toxo M)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 22, 2022

IMMULITE SYSTEMS Ferritin Control Module

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 22, 2022

ADVIA Chemistry Cholesterol_2(CHOL ) Reagents Reagent

Manufacturer:

RANDOX LABORATORIES LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 18, 2022

ATELLICA IM Toxoplasma IgG Quality Control (Toxo G QC)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 17, 2022

ADVIA Centaur Toxoplasma M

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 8, 2022

ADVIA Centaur Toxoplasma G Quality Control (Toxo G QC)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 8, 2022

ADVIA Centaur Toxoplasma G (Toxo G)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 8, 2022

ADVIA 1800 Chemistry System and Accessories.

Manufacturer:

JEOL LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 26, 2022

CoV2Ag Sample Lysis Reagent

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2022

CORPATH GRX System

Manufacturer:

CORINDUS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 22, 2022

Atellica IM Wash

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 17, 2022

Atellica™ IM Multi-Diluent 2.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 11, 2022

Atellica IM BRAHMS Procalcitonin Quality Control (PCT QC)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 11, 2022

Multix Impact

Manufacturer:

SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 9, 2022

ATELLICA ™ IM Progesterone (PRGE).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 6, 2022

Atellica Decapper

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 4, 2022

ATELLICA ™ IM Homocysteine Diluent (HCY DIL)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 31, 2021

Atellica™ IM Hepatitis B e Antigen Quality Control (HbeAg QC)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 28, 2021

Atellica™ IM hepatitis C (aHCV).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 27, 2021

ATELLICA™ IM Homocysteine (HCY)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 24, 2021

ATELLICA™ IM Hepatitis B surface Antigen II Quality Control (HbsII QC)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 24, 2021

Atellica IM Free Thyroxine (FT4).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 23, 2021

ADVIA 120/ADVIA 2120/ADVIA 2120i 3in1 TESTpoint Hematology Controls

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 15, 2021

ATELLICA ™ IM Free Triiodothyronine (FT3).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 14, 2021

Atellica CH Chemistry Calibrator (CHEM CAL).

Manufacturer:

FISHER DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 10, 2021

ATELLICA IM Free Prostate-Specific Antigen Calibrator (fPSA CAL)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 10, 2021

ATELLICA IM Ferritin (Fer).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 7, 2021

Atellica IM Creatine Kinase MB (CKMB)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 1, 2021

ATELLICA™ IM Enhanced Estradiol Diluent (eE2 DIL).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 1, 2021

Atellica™ IM Creatine Kinase MB Calibrator (CKMB CAL).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 1, 2021

ATELLICA ™ IM eE2

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 1, 2021

Atellica IM Caecinoembryonic Antigen Diluent (CEA DIL).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 1, 2021

ATELLICA IM Complexed Prostate-Specific Antigen Quality Control (cPSA QC)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 29, 2021

Atellica CH Cholinesterase (THAT).

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 24, 2021

ADVIA 120/ ADVIA 2120/ ADVIA 2120i OPTIpoint

Manufacturer:

FISHER DIAGNOSTICS,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 24, 2021

ADVIA 120/ADVIA 2120/ADVIA 2120i TESTPOINT Control High

Manufacturer:

DASH INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 19, 2021

Atellica IM Carcinoembryonic Antigen (CEA).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 19, 2021

ADVIA Chemistry Uric Acid Reagents.

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 14, 2021

Atellica IM Calibrator C (CAL C).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 10, 2021

Atellica IM Anti-Hepatitis B surface Antigen 2 Quality Control (aHBs2 QC).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 10, 2021

Atellica™ IM Calibrator E (CAL E).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 9, 2021

ATELLICA™ IM Hepatitis C Quality Control (aHCV QC)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 9, 2021

Atellica™ IM Calibrator 1 (CAL 1).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 9, 2021

Atellica IM Calibrator B (CAL B)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 9, 2021

Atellica IM Cleaner.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 30, 2021

ADVIA 120/ADVIA 2120/ADVIA 2120i TESTpoint CSF Controls.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 28, 2021

ADVIA 120/ADVIA 2120/ADVIA 2120i SETPOINT™ Cal.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 28, 2021

ATELLICA IM Anti-Thyroglobulin (aTG)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2021

Atellica IM Anti-Thyroglobulin Diluent (aTG DIL).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2021

ATELLICA™ IM Anti-Thyroglobulin Quality Control (aTG QC)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2021

ATELLICA IM Anti-Thyroid Peroxidase Diluent (aTPO DIL)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2021

Atellica™ IM Hepatitis A Total Quality Control (aHAVT QC).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 24, 2021

DIMENSION EXL™ SARS-CoV-2 IgG (CV2G)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 20, 2021

ATELLICA™ IM CA 125II™ Calibrator (CA 125II CAL).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 18, 2021

ATELLICA IN CA 19-9 (CA 19-9).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 18, 2021

ATELLICA IN CA 19-9 Diluent (CA 19-9 DIL).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 18, 2021

Atellica IM Hepatitis A IgM (aHAVM).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 14, 2021

ATELLICA IM Hepatitis A Total (aHAVT)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 14, 2021

DIMENSION VISTA / DIMENSION EXL™ SARS-CoV-2 IgG Quality Control

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 11, 2021

ATELLICA IM Thyroglobulin (Tg) ReadyPack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 25, 2021

ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein Calibrator.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 21, 2021

Atellica CH Total Protein II (TP)

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 15, 2021

ATELLICA CH Uric Acid (UA)

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 15, 2021

ATELLICA CH Urea Nitrogen (UN_c)

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 15, 2021

ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.(NEWARK)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 8, 2021

ATELLICA CH Total Iron Binding Capacity (TIBC)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 8, 2021

ADVIA Chemistry CHE Cholinesterase Reagents.

Manufacturer:

RANDOX LABORATORIES LTD.,

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 4, 2021

ADVIA Chemistry Inorganic Phosphorus Reagents.

Manufacturer:

RANDOX LABORATORIES LTD.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 3, 2021

ATELLICA CH Mg

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 2, 2021

ATELLICA CH Prealbumin (PreAlb)

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 2, 2021

MAGNETOM Free.Max

Manufacturer:

SIEMENS HEALTHCARE GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 1, 2021

Atellica CH Water Bath Additive (WBA).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 1, 2021

Atellica CH Lipoprotein(a) (Lp(a)).

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 30, 2021

ATELLICA CH Liquid Specific Protein Calibrators (LSP CAL).

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 30, 2021

ATELLICA CH Microalbumin_2 (µALB_2)

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 21, 2021

ATELLICA CH PAMY 2

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 21, 2021

ADVIA Centaur COV2T Readypack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 19, 2021

Atellica CH Reagent Probe Cleaner 4 (RPC4).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 17, 2021

ADVIA Centaur COV2T QC

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2021

Atellica CH Iron_2 (Iron_2).

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2021

ATELLICA CH Lipoprotein(a) Calibrator (Lp(a) CAL)

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2021

Atellica CH ENZ 2 Calibrator (ENZ 2 CAL).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 10, 2021

ARCADIS Orbic

Manufacturer:

SIEMENS HEALTHCARE GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 6, 2021

ATELLICA CH Enzymatic Creatinine_2 (Ecre_2)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 6, 2021

ATELLICA CH ENZ 1 CAL

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. NEWARK

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 5, 2021

Atellica CH Lactate Dehydrogenase L-P (LDLP).

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 2, 2021

ATELLICA CH High Sensitivity C-Reactive Protein (hsCRP)

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 30, 2021

ATELLICA CH GGT

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2021

ATELLICA CH HDL/LDL CAL

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2021

ADVIA Centaur HCV Ready Pack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 27, 2021

ATELLICA CH LDL Cholesterol Direct (DLDL)

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 26, 2021

ARCADIS Avantic

Manufacturer:

SIEMENS HEALTHCARE GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 23, 2021

Atellica CH C-Reactive Protein_2 Calibrators (CRP_2 CAL).

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 22, 2021

ARCADIS Varic

Manufacturer:

SIEMENS HEALTHCARE GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 22, 2021

ATELLICA CH Direct HDL Cholesterol (D-HDL).

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 22, 2021

ATELLICA CH hsCRP CAL

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 21, 2021

Atellica CH Cystatin C_2 Calibrators (CYSC_2 CAL)

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 21, 2021

ATELLICA CH Cocaine Metabolite (Coc)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 15, 2021

Atellica CH Direct Bilirubin 2 (DBil_2).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 14, 2021

Atellica IM NT-proBNP (PBNP) Ready Pack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 14, 2021

Atellica CH Ethyl Alcohol (ETOH)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 14, 2021

Atellica IM Interleukin-6 (IL6) Ready Pack

Manufacturer:

AXIS-SHIELD DIAGNOSTICS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 7, 2021

CIOS FIT

Manufacturer:

SIEMENS HEALTHCARE PVT. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 2, 2021

DIMENSION Clinical Chemistry System ALDL Calibrator.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 28, 2021

DIMENSION MALB Calibrator.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 28, 2021

DIMENSION ALB Flex Reagent Cartridge.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 28, 2021

ADVIA Centaur Total IgE Ready Pack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 22, 2021

Atellica CH CHEM III Calibrator (CHEM III CAL).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 21, 2021

ATELLICA CH Cholesterol_2 (Chol_2).

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 21, 2021

ADVIA Chemistry ALT Alanine Aminotransferase Reagents

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 18, 2021

DIMENSION EXL LOCI High Sensitivity Troponin I Flex Reagent Cartridge.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 18, 2021

Dimension EXL™ LOCI Module High Sensitivity Troponin I Calibrator

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 17, 2021

ADVIA Centaur BRAHMS Procalcitonin (PCT) Ready Pack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 16, 2021

ADVIA Centaur T3 Ready Pack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 11, 2021

ADVIA Chemistry CA_2 Calcium Reagents 2

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 10, 2021

Dimension EXL™ SARS-CoV-2 Total antibody assay (CV2T)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 10, 2021

ADVIA Chemistry APO-A1 Reagents

Manufacturer:

RANDOX LABORATORIES, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 10, 2021

ADVIA Chemistry HDL/LDL Cholesterol Calibrator.

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 10, 2021

ADVIA Chemistry Albumin Reagent

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 10, 2021

ATELLICA CH Urinary/Cerebrospinal Fluid Protein Calibrators (UCFP CAL)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 3, 2021

ATELLICA CH Complement C3 (C3).

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 3, 2021

Atellica CH Aspartate Aminotransferase (AST).

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 28, 2021

DIMENSION Clinical Chemistry System TP/ALB Calibrator

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 21, 2021

Atellica CH Complement C4 (C4).

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2021

Atellica CH Anti-Streptolysin-O_2 (ASO_2).

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 17, 2021

ATELLICA CH Apolipoprotein A-1 (APO A1).

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 17, 2021

Atellica CH Apolipoprotein B (APO B).

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 17, 2021

ADVIA Centaur VB12 DTT/Releasing Agent

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 11, 2021

Atellica CH Apolipoprotein A1 & B Calibrator (APO A1 & B CAL).

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 11, 2021

Atellica CH A-LYTE™ IMT Integrated Multisensor (IMT Na K Cl).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 11, 2021

HEMATEK Stain Pak - Modified Wright's Stain

Manufacturer:

RICHARD-ALLAN SCIENTIFIC CO.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 9, 2021

ATELLICA CH Amylase (Amylas) AMY 2

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 7, 2021

DIMENSION MALB Flex Reagent Cartridge.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 6, 2021

ADVIA Centaur FT3 Ready Pack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 6, 2021

ADVIA Centaur BRAHMS Procalcitonin Quality Control (PCT QC)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 5, 2021

DIMENSION VISTA /DIMENSION EXL™ SARS-CoV-2 Total antibody Calibrator

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 5, 2021

ADVIA Centaur Multi-Diluent 1 Ready Pack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 5, 2021

QUIKLYTE Integrated Multisensor Standard B

Manufacturer:

NOVA BIOMEDICAL CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 5, 2021

DIMENSION Clinical Chemistry System PCHE Verifier.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 4, 2021

ADVIA Centaur HCV Quality Control

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 1, 2021

HEMATEK Stain Pak – Wright-Giemsa Stain

Manufacturer:

RICHARD-ALLAN SCIENTIFIC CO.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 1, 2021

Atellica CH A-LYTE™ IMT Dilution Check.

Manufacturer:

FISHER DIAGNOSTICS

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 1, 2021

ADVIA Chemistry Enzyme 2 Calibrator.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 1, 2021

EPOC NXS Host and Accessories

Manufacturer:

EPOCAL INC.(BROOKFIELD ROAD)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 1, 2021

ADVIA Centaur HBc IgM ReadyPack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 19, 2021

ATELLICA CH A-LYTE IMT Standard A

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 19, 2021

Atellica CH A-LYTE™ IMT Diluent.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 19, 2021

ATELLICA CH Alkaline Phosphatase_2 Calibrator (ALP_2 CAL)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 13, 2021

ADVIA Centaur HAV IgM Ready Pack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 13, 2021

Atellica CH Alkaline Phosphatase, Concentrated (ALP_2c)

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 13, 2021

Atellica CH A1c_E CAL (Enzymatic Hemoglobin A1c_E Calibrator)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 12, 2021

ATELLICA CH Alanine Aminotransferase (ALT)

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 12, 2021

ATELLICA CH Enzymatic Hemoglobin A1c (A1c_E)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 12, 2021

ADVIA Chemistry Enzyme 1 Calibrator.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 9, 2021

ADVIA Centaur ThCG Ready Pack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 7, 2021

ADVIA Centaur CAL CKMB Calibrator

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 7, 2021

ADVIA Centaur PRGE Ready Pack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 7, 2021

ADVIA Centaur FSH Ready Pack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 7, 2021

ADVIA Centaur PRL Ready Pack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 7, 2021

ADVIA Centaur HAV IgM QC

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 30, 2021

ADVIA Centaur Systems aHAVT QC

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 30, 2021

ADVIA Chemistry Enzyme 3 Calibrator.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 25, 2021

ADVIA Centaur aHAVT ReadyPack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 23, 2021

ADVIA Centaur Systems Calibrator 80

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 23, 2021

ADVIA Centaur TST II ReadyPack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 18, 2021

ADVIA Centaur MYO Readypack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 11, 2021

ADVIA Centaur HCY Calibrator

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 22, 2021

ADVIA Centaur HCY

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 19, 2021

IMMULITE 1000 Systems T3F Free T3

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 19, 2021

ADVIA Centaur HCY Diluent

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 19, 2021

IMMULITE 2000 Systems HCG

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 16, 2021

IMMULITE 1000 Systems TES Total Testosterone

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 16, 2021

DIMENSION EXL™ Integrated Chemistry System LOCI Module FLEX Reagent Cartridge TSHL

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 16, 2021

ADVIA Centaur BNP Calibrator

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 15, 2021

DIMENSION EXL ™ LOCI Module FT3 Flex Reagent Cartridge

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 15, 2021

DIMENSION FERR Calibrator

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 15, 2021

ADVIA Centaur Calibrator 28

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 11, 2021

ADVIA Centaur PHNB ReadyPack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 11, 2021

ADVIA Centaur Calibrator C

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 11, 2021

ADVIA Centaur PHTN

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 7, 2021

ADVIA Centaur BNP 1,2,3 QC

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 7, 2021

DIMENSION ECO2 Flex Reagent Cartridge

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 4, 2021

SIEMENS ADVIA Centaur GENT ReadyPack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 4, 2021

ADVIA Centaur Vitamin D Diluent ReadyPack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 4, 2021

ADVIA Centaur SHBG Calibrator

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 29, 2020

DIMENSION EXL™ LOCI Module FT4L Flex Reagent Cartridge

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 26, 2020

ADVIA Centaur Multi-Diluent 2

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 26, 2020

DIMENSION EXL ™ Integrated Chemistry System LOCI Module LOCI TNI CAL

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 22, 2020

DIMENSION EXL ™ Integrated Chemistry System LOCI Module LOCI NTP CAL

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 21, 2020

ADVIA Centaur QC PTH

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 21, 2020

DIMENSION EXL LOCI Module Loci Thyr Cal

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 11, 2020

ADVIA Centaur Anti-TPO

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 7, 2020

ADVIA Centaur aTPO Diluent

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 3, 2020

ADVIA Centaur ™ PTH

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 2, 2020

ADVIA Centaur HER-2/neu Calibrator

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 1, 2020

ADVIA Centaur H2n (HER-2/neu) Quality Control

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 1, 2020

DIMENSION Heterogeneous Immunoassay Modul Flex Reagent Cartridge CCRP

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 29, 2020

DIMENSION EXL ™/Dimension Vista Multi 2 SDIL

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 29, 2020

IMMULITE 2000 Systems SPG Allergen-Specific IgG

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 26, 2020

Dimension® Clinical Chemistry System CCRP Calibrator

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 25, 2020

Dimension® EXL Integrated Chemistry System LOCI Module Flex Reagent Cartridge NTP

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 23, 2020

DIMENSION Vista /DIMENSION EXL ™ CTNI SDIL

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 20, 2020

ADVIA Centaur HER-2/neu (H2n)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 13, 2020

Dimension CSA FLEX Reagent Cartridge

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 10, 2020

ADVIA Chemistry Glucose Hexokinase_3 (GLUH_3)Reagents

Manufacturer:

RANDOX LABORATORIES LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 9, 2020

ADVIA Centaur Folate (FOL)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.(EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 3, 2020

ADVIA Centaur HBsAg Confirmatory

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC., USA (EAST WALPOLE)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 2, 2020

ADVIA Centaur Enhanced Estradiol (eE2) Diluent Ready Pack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.(EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 26, 2020

ADVIA Centaur Anti-HBe

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.(EAST WALPOLE)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 26, 2020

ADVIA Centaur Anti CCP Quality Control (QC)

Manufacturer:

AXIS-SHIELD DIAGNOSTICS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 26, 2020

ADVIA Centaur cPSA

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 26, 2020

ADVIA Centaur Calibrator 30

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 26, 2020

ADVIA Centaur Total IgE Diluent

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 20, 2020

ADVIA Centaur BR

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 20, 2020

ADVIA Centaur SHBG ReadyPack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 20, 2020

ADVIA wr CRP (Wide Range C-Reactive Protein) Reagents

Manufacturer:

RANDOX LABORATORIES, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 16, 2020

ADVIA Chemistry Lipase Reagents

Manufacturer:

RANDOX LABORATORIES LTD. UK

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 16, 2020

ADVIA Chemistry wr CRP Calibrators

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 15, 2020

ADVIA Chemistry TIBC Reagents

Manufacturer:

FISHER DIAGNOSTICS A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 14, 2020

ADVIA Centaur (CAL) Calibrator Q

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 14, 2020

ADVIA Centaur Anti-CCP (aCCP)

Manufacturer:

AXIS-SHIELD DIAGNOSTICS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 13, 2020

IMMULITE 2000 Third Generation TSH Sample Diluent

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 13, 2020

ADVIA Chemistry ALP_2 Calibrator

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK).

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 12, 2020

ADVIA Centaur CA 19-9 Diluent

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.(EAST WALPOLE),

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 12, 2020

ADVIA Centaur HBsII

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.(EAST WALPOLE)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 8, 2020

ADVIA Centaur CKMB ReadyPack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 8, 2020

ADVIA Centaur Multi Diluent 11 ReadyPack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 8, 2020

ADVIA Centaur HBsAg Ready Pack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.(EAST WALPOLE)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 8, 2020

SIEMENS AI-RAD COMPANION

Manufacturer:

SIEMENS HEALTHCARE GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 1, 2020

ATELLICA IM LH

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.(EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 1, 2020

ADVIA Centaur HBc Total Quality Control (HBcT QC)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC., (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 30, 2020

ATELLICA IM Vitamin B12 DTT/Releasing Agent (DTT/REL)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.(EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 29, 2020

ADVIA Centaur HBc IgM Quality Control (aHBcM QC)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 29, 2020

ADVIA Centaur Anti-HBe (aHBe) Quality Control

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 23, 2020

Atellica IM Vitamin B12 (VB12)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 23, 2020

ATELLICA IM VB12 Dil

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 22, 2020

EPOC™ HOST 2 and accessories

Manufacturer:

EPOCAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 22, 2020

ATELLICA IM aCCP QC

Manufacturer:

AXIS-SHIELD DIAGNOSTICS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 17, 2020

ATELLICA IM Cor

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 17, 2020

ADVIA Centaur Calibrator 1

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 17, 2020

ADVIA Centaur anti TPO 1,2 QC

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 17, 2020

Atellica IM Anti-CCP (aCCP)

Manufacturer:

AXIS-SHIELD DIAGNOSTICS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 14, 2020

ATELLICA IN THE TSTII

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 14, 2020

ATTELICA IM Multi-Diluent 3

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 14, 2020

Atellica IM Vitamin D Total (Vit D)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 12, 2020

Atellica IM Folate DTT/Releasing Agent

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 9, 2020

ATELLICA IM Fol DIL

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 8, 2020

ATELLICA IM RBC Fol

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.(EAST WALPOLE).

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 8, 2020

ATELLICA IM VitD QC

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 8, 2020

ATELLICA IM Vitamin D Total Diluent (VitD Dil)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.(WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 4, 2020

ATELLICA IM FOLATE (Fol)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 2, 2020

IMMULITE Insulin Control Module

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 28, 2020

ADVIA Centaur IL-6

Manufacturer:

AXIS-SHIELD DIAGNOSTICS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 12, 2020

Dimension® Thyroid Stimulating Hormone Flex® reagent cartridge

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 24, 2020

RAPIDLAB 1200 Blood Gas Analyzer and Accessories

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 9, 2020

IMMULITE Systems TSH Control Third Generation TSH

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 25, 2020

Immulite 2000 Third Generation TSH

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 25, 2020

IMMULITE HCG Control Module

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 25, 2020

SIEMENS syngo Dynamics

Manufacturer:

SIEMENS MEDICAL SOLUTIONS USA, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 17, 2020

Atellica CH Amylase_2

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 15, 2020

ADVIA Centaur Wash 1

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 30, 2020

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

Last updated: December 2025