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SIEMENS HEALTHINEERS INDONESIA

Authorized Representative in Indonesia

Perkantoran Hijau Arkadia Tower F, Lantai 18, Jl.Tahi Bonar Simatupang Kav. 88
373 Products Represented
77 Manufacturers
Total Products
373
Manufacturers
77
Product Classes
3
Risk Classes
4
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
37 products
9.9%
Kelas Resiko : B
225 products
60.3%
Kelas Resiko : C
106 products
28.4%
Kelas Resiko : D
5 products
1.3%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (373)
Complete portfolio registered with BPOM

IMMULITE 2000 Substrate Module 2000T

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 10, 2025

DIMENSION GGT Flex Reagent Cartridge

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 10, 2025

DIMENSION MBI Flex reagent cartridge

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 10, 2025

Dimension Alkaline Phosphatase Calibrator ( ALPI CAL )

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 10, 2025

IMMULITE 2000 Systems GRH Growth Hormone

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 10, 2025

Dimension Automated HDL Cholesterol Flex (AHDL)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 10, 2025

DIMENSION Creatinine Flex reagent cartridge (CRE2)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 10, 2025

DIMENSION Clinical Chemistry System Flex Reagent Cartridge PCHE.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 10, 2025

ADVIA Centaur VB12 Diluent Ready Pack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 7, 2025

DIMENSION Magnesium Flex (MG)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2025

DIMENSION Iron Flex reagent cartridge

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC .

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2025

QUIKLYTE Integrated Multisensor Sample Diluent.

Manufacturer:

NOVA BIOMEDICAL CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2025

DIMENSION Cholesterol Calibrator (CHOL CAL)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2025

DIMENSION CHK FLEX Reagent Cartridge

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 6, 2025

DIMENSION AMY Flex Reagent Cartridge.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2025

DIMENSION Alanine Aminotransferase Flex Reagent Cartridge (ALTI)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2025

Dimension Phosphorus Flex (PHOS) reagent cartridge

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2025

DIMENSION Chemistry III Calibrator (CHEM III CAL)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2025

IMMULITE/IMMULITE 1000 Gastrin

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 5, 2025

ADVIA Centaur T4 Diluent

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 5, 2025

IMMULITE 2000 IGFBP-3

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 5, 2025

QUIKLYTE Integrated Multisensor Flush Solution

Manufacturer:

NOVA BIOMEDICAL CORPORATION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 5, 2025

DIMENSION TP Flex Reagent Cartridge

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 5, 2025

IMMULITE 1000 Substrate Module 1000T

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 5, 2025

ADVIA Centaur Acid/Base Reagents

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 4, 2025

ADVIA Centaur SYPH Ready Pack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 4, 2025

DIMENSION Clinical Chemistry System FLEX Reagent Cartridge CA

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 3, 2025

DIMENSION Chemistry II Calibrator (CHEM II CAL)

Manufacturer:

FISCHER DIAGNOTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2025

ADVIA Centaur Insulin Calibrator (IRI CAL)

Manufacturer:

MINARIS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2025

AI-Rad Companion Organs RT

Manufacturer:

SIEMENS HEALTHINEERS AG., GERMANY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 30, 2025

QuikLYTE Integrated Multisensor

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 24, 2025

DIMENSION Special Protein Calibrator

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC .

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 23, 2025

IMMULITE 2000 XPI

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC..

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 15, 2025

DIMENSION clinical chemistry system C4 FLEX Reagent Cartridge

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 15, 2025

ADVIA Centaur Vitamin D Total Quality Control Material

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 15, 2025

IMMULITE 3gAllergy™ Specific IgE Negative Control

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 15, 2025

Q-ity UA 10 Visual Urine Strip

Manufacturer:

KIMBALL ELECTRONICS POLAND SP Z 0.0

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 14, 2025

CHEK-STIX Combo Pak Control Strip for Urinalysis

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 14, 2025

DIMENSION AST FLEX Reagent Cartridge.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 14, 2025

IMMULITE/ IMMULITE 1000 Systems CMV IgM

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LT

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 13, 2025

IMMULITE 2000 Total IgE

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 13, 2025

IMMULITE 1000 Systems CMV IgG

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 13, 2025

ADVIA 120/ADVIA 2120/ADVIA 2120i EZ WASH.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 9, 2025

DIMENSION TRNF Flex Reagent Cartridge

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 9, 2025

RAPIDLAB Wash 348 & CD Pack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS, MANUFACTURING LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 9, 2025

SIEMENS MULTISTIX 10 SG Reagent Strip.

Manufacturer:

KIMBALL ELECTRONICS POLAND SP. Z.O.O.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 9, 2025

ATELLICA™ CH 930 Analyzer & Accessories

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 9, 2025

SIEMENS RAPID QC Complete Level 2

Manufacturer:

BIONOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 8, 2025

ADVIA Centaur Systems CEA Diluent Ready Pack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 8, 2025

RAPIDPOINT 500e Blood Gas System and Accessories

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 8, 2025

IMMULITE Probe Wash Module

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 7, 2025

IMMULITE 1000 Systems Herpes I & II IgG

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 7, 2025

DIMENSION EZCR Enzymatic Creatinine Flex Reagent Cartridge

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 6, 2025

Dimension® Lipase Flex® reagent cartridge

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 24, 2024

CIOS Spin

Manufacturer:

SIEMENS HEALTHINEERS AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 19, 2024

CIOS Alpha

Manufacturer:

SIEMENS HEALTHINEERS AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 19, 2024

ARTIS Zee Multi-purpose

Manufacturer:

SIEMENS HEALTHINEERS AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 19, 2024

ARTIS Q.zen floor

Manufacturer:

SIEMENS HEALTHINEERS, AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 17, 2024

ARTIS Zee Biplane

Manufacturer:

SIEMENS HEALTHINEERS, AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 17, 2024

MAGNETOM Vida Fit

Manufacturer:

SIEMENS HEALTHINEERS AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 17, 2024

ARTIS One

Manufacturer:

SIEMENS SHENZHEN MAGNETIC RESONANCE LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 17, 2024

ARTIS Q.zen Ceiling

Manufacturer:

SIEMENS HEALTHINEERS AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 17, 2024

AMIRA MAGNET

Manufacturer:

SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 16, 2024

ARTIS Q Ceiling

Manufacturer:

SIEMENS HEALTHINEERS AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 12, 2024

ARTIS Q.zen biplane

Manufacturer:

SIEMENS HEALTHINEERS, AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 12, 2024

IMMULITE1000 Rubella IgG

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 11, 2024

ARTIS Q Biplane

Manufacturer:

SIEMENS HEALTHINEERS, AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 11, 2024

ARTIS Zee Ceiling

Manufacturer:

SIEMENS HEALTHINEERS AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 11, 2024

ARTIS Q Floor

Manufacturer:

SIEMENS HEALTHINEERS AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 11, 2024

SOMATOM go. All

Manufacturer:

SIEMENS HEALTHINEERS AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 10, 2024

SOMATOM go. Top

Manufacturer:

SIEMENS HEALTHINEERS AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 9, 2024

MAGNETOM SEMPRA

Manufacturer:

SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 9, 2024

MAGNETOM Vida

Manufacturer:

SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 2, 2024

SYNGO Dynamics

Manufacturer:

SIEMENS MEDICAL SOLUTIONS USA, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 2, 2024

MAGNETOM Lumina

Manufacturer:

SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 2, 2024

MAGNETOM Vida

Manufacturer:

SIEMENS HEALTHINEERS AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 2, 2024

YSIO Max

Manufacturer:

SIEMENS HEALTHINEERS AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 28, 2024

Dimension EXL 200 Integrated Chemistry System

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 28, 2024

ARTIS Floor Icon

Manufacturer:

SIEMENS HEALTHINEERS AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 26, 2024

ARTIS Pheno

Manufacturer:

SIEMENS HEALTHINEERS AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 26, 2024

IMMULITE Total IgE Control Module

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 19, 2024

NAEOTOM Alpha

Manufacturer:

SIEMENS HEALTHINEERS, AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 19, 2024

SOMATOM go. Now

Manufacturer:

SIEMENS HEALTHINEERS AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 19, 2024

MAGNETOM Free.Star

Manufacturer:

SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 18, 2024

SYNGO. VIA

Manufacturer:

SIEMENS HEALTHINEERS AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 18, 2024

MAGNETOM Lumina

Manufacturer:

SIEMENS HEALTHINEERS AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 17, 2024

LUMINOUS Impulse

Manufacturer:

SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 15, 2024

LUMINOUS Agile Max

Manufacturer:

SIEMENS HEALTHINEERS AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 14, 2024

IMMULITE 2000 3g Allergy Specific IgE Sample Diluent

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 14, 2024

MAMMOMAT Fusion

Manufacturer:

SIEMENS HEALTHINEERS AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 14, 2024

BRIGHT Lotus Max

Manufacturer:

SIEMENS HEALTHINEERS AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 14, 2024

AI-Rad Companion Pulmonary

Manufacturer:

SIEMENS HEALTHINEERS AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 1, 2024

Magnetom Flow.Ace

Manufacturer:

SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 18, 2024

Magnetom Flow.Ace

Manufacturer:

SIEMENS HEALTHINEERS AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 9, 2024

Magnet Flow.Plus

Manufacturer:

SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 8, 2024

N Latex ADnase B

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 20, 2024

SIEMENS N Protein Control LC1

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 20, 2024

SIEMENS N Protein Control LC2

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 20, 2024

N Antiserum Human Albumin

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 17, 2024

SIEMENS N Antiserum to Human Antithrombin III

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 12, 2024

SIEMENS N Latex Beta 2–Microglobulin

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 12, 2024

SIEMENS N Latex Lp(a) Reagent

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 12, 2024

Acuson Sequoia Select

Manufacturer:

SIEMENS MEDICAL SOLUTIONS USA, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 12, 2024

SIEMENS HEALTHINEERS N Protein Standard SL

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 10, 2024

SIEMENS N Latex IgE mono

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 9, 2024

SIEMENS N Antiserum to Human Hemopexin

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 9, 2024

SIEMENS N FLC Standard SL

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 3, 2024

SIEMENS N Antiserum to Human Alpha-1-acid Glycoprotein

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 2, 2024

SIEMENS N a1-Microglobulin Kit

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 31, 2024

SIEMENS N Lp(a) Standard SY

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 31, 2024

SIEMENS N Latex sTfR

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 30, 2024

SIEMENS N Reaction Buffer

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 26, 2024

SIEMENS N Antiserum to Human IgG

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 19, 2024

SIEMENS N Antiserum to Human Retinol-binding Protein (RbP)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 19, 2024

SIEMENS N FLC Supplementary Reagent

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 14, 2024

SIEMENS N/T Protein Control SL/M

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 13, 2024

Pathonorm Cardiac Acute Liq

Manufacturer:

SERO AS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2024

SIEMENS N Antiserum to Human C3c

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 5, 2024

SIEMENS N Antiserum to Human Fibronectin

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 1, 2024

SIEMENS NOR-Partigen C3c

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2024

SIEMENS N Supplementary Reagent L

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 1, 2024

SIEMENS N Latex Cystatin C

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2024

SIEMENS N Latex FLC Kappa

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 27, 2024

SIEMENS N Latex BTP

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 27, 2024

SIEMENS N Antiserum to Human IgA ( α -chain)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2024

SIEMENS N Antiserum to Human C4

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2024

SIEMENS N/T Rheumatology Control SL/2

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 24, 2024

SIEMENS N Antiserum to Human IgM

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 22, 2024

SIEMENS N Antiserum to Human Prealbumin

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 28, 2023

SIEMENS N Latex FLC Lambda

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 28, 2023

SIEMENS N Diluent

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 28, 2023

SIEMENS N/T Protein Control SL/H

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2023

SIEMENS N Supplementary Reagent/Precipitation

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH .

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 22, 2023

SIEMENS N Rheumatology Standard SL

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 13, 2023

SIEMENS N Latex ASL

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 13, 2023

AI-Rad Companion Brain MR

Manufacturer:

SIEMENS HEALTHCARE GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 28, 2023

SIEMENS N Lp (a) Control SY

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2023

Acuson NX3 Elite

Manufacturer:

SIEMENS HEALTHCARE S.R.O

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 20, 2023

ATELLICA IM HBc Total 2 (HBcT2)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 30, 2023

Dimension Immunoglobulin G Flex reagent cartridge(IgG)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 2, 2023

IMMULITE 1000 TNFa

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 2, 2023

AI-Rad Companion Chest X-ray

Manufacturer:

SIEMENS HEALTHCARE GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 28, 2023

Somatom X.cite

Manufacturer:

SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 25, 2023

IMMULITE 2000 Herpes I & II IgG

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 11, 2023

IMMULITE 2000 D -DIMER

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 11, 2023

IMMULITE Rubella IgM Controls

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 11, 2023

Acuson Redwood

Manufacturer:

SIEMENS HEALTHCARE S.R.O

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 7, 2023

EUROTROL Hct Control Level B.

Manufacturer:

EUROTROL B.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 17, 2023

Acuson X700

Manufacturer:

SIEMENS HEALTHINEERS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 16, 2023

ANZAI Respiratory Gating System

Manufacturer:

ANZAI MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 12, 2023

IMMULITE CMV IgG Controls

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 7, 2023

IMMULITE Toxoplasma IgG Controls

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 5, 2023

IMMULITE Rubella IgG Controls

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 5, 2023

DCA System Microalbumin/Creatinine Control

Manufacturer:

FISCHER DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 26, 2023

IMMULITE 2000 CMV IgM

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 3, 2023

ADVIA Centaur Herpes-2 IgG (HSV2)

Manufacturer:

BIOKIT, S.A. SPAIN.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 10, 2023

Emit II Plus 6-Acetylmorphine Assay

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC., USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

Emit II Plus Ecstasy Assay

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC., USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

Emit Ethyl Alcohol 100 mg/dL Calibrator

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC., USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

Emit II Plus 6-AM/Ecstasy Calibrator/Control Level 2

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC., USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 25, 2023

Emit Ethyl Alcohol Low Control

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC., USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

Emit II Plus Phencyclidine Assay

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC., USA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

IMMULITE 1000 H.Pylori/Lyme AB Screen Sample Diluent Infectious Disease 2 (ID2)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 31, 2022

ACUSON Sequoia

Manufacturer:

SIEMENS MEDICAL SOLUTIONS USA, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 29, 2022

ACUSON Freestyle Diagnostic Ultrasound System

Manufacturer:

SIEMENS MEDICAL SOLUTIONS USA, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 29, 2022

ACUSON Juniper Diagnostic Ultrasound System

Manufacturer:

SIEMENS HEALTHINEERS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2022

Clinitek HCG Test Kit

Manufacturer:

ALFA SCIENTIFIC DESIGNS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 21, 2022

ADVIA Chemistry Amylase Reagents..

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 19, 2022

IMMULITE 1000 Free Beta HCG

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 19, 2022

IMMULITE Thyroglobulin Sample Diluent..

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 14, 2022

Atellica IM AMH Quality Control (AMH QC)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 5, 2022

SENTINEL DIAGNOSTICS RF Cal Set

Manufacturer:

SENTINEL CH SPA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 25, 2022

Atellica CH Cholinesterase_2 (CHE_2)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. USA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 25, 2022

N AS IgG 2

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 14, 2022

IMMULITE 1000 Systems TSH Third Generation…

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 2, 2022

IMMULITE system C-Peptide Control Module

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2022

IMMULITE 1000 Systems Toxoplasma Quantitative IgG

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 20, 2022

Atellica IM CMV IgG Quality Control (CMV IgG QC)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 13, 2022

IMMULITE Estradiol Sample Diluent..

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 10, 2022

EUROTROL EPOC Calibration Verification Fluids..

Manufacturer:

EUROTROL B. V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 10, 2022

IMMULITE 1000 Systems HCG

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 5, 2022

IMMULITE 1000 Systems Total T3

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 5, 2022

IMMULITE 1000 Systems Total T4

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 5, 2022

IMMULITE 1000 ACTH Sample Diluent

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 3, 2022

IMMULITE1000 Systems DHS DHEA-SO4

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 29, 2022

IMMULITE 1000 Systems PRL Prolactin

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 28, 2022

IMMULITE 2000 C-Peptide Sample Diluent..

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 27, 2022

IMMULITE 1000 Calcitonin

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 27, 2022

IMMULITE 1000 Systems TG Thyroglobulin.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 27, 2022

EUROTROL Hct Control Level C.

Manufacturer:

EUROTROL B. V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 26, 2022

Atellica IM CMV IgM (CMV IgM)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. USA..

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 21, 2022

EPOC Blood Analysis BGEM Test Card

Manufacturer:

EPOCAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 6, 2022

IMMULITE 1000 LH

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 1, 2022

FTD Respiratory Pathogens 21

Manufacturer:

FAST TRACK DIAGNOSTICS LUXEMBOURG S.á.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 31, 2022

RAPIDLAB 1200 Wash Cartridge Kit

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 30, 2022

CLINITEK Novus 12 Urinalysis Cassette

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS, INC. (MISHAWAKA)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 29, 2022

IMMULITE 1000 Progesterone

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2022

ADVIA CENTAUR® ThCG Diluent

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC., UNITED STATES

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 22, 2022

Atellica HEMA Diff

Manufacturer:

HORIBA ABX SAS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 15, 2022

Dimension Lipase Flex reagent cartridge

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2022

ADVIA Centaur XP Immunoassay System

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD. IRELAND

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 11, 2022

IMMULITE 1000 IgG/IgM (ID1) Sample Diluent

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 27, 2022

IMMULITE 2000 Multi-Diluent 2

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 27, 2022

AI-Rad Companion Chest X-ray

Manufacturer:

SIEMENS HEALTHCARE GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 17, 2022

ADVIA Chemistry Calibrator

Manufacturer:

FISHER DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2022

ADVIA Centaur CMV IgM (CMV IgM) ReadyPack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC., WALPOLE, USA UNTUK SIEMENS HEALTHCARE DIAGNOSTICS INC., TARRYTOWN, USA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 7, 2022

Dimension Cyclosporine Extended Range Calibrator

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2022

DIMENSION AHDL Calibrator

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC .

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 3, 2022

DIMENSION EXL LOCI Module LOCI VB12 Flex reagent cartridge

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 31, 2022

DIMENSION Salt Bridge Solution

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 25, 2022

ADVIA 360 Lyse 3P Diff

Manufacturer:

DIATRON MI PLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 22, 2022

EUROTROL Hct Control Level A

Manufacturer:

EUROTROL B. V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 22, 2022

IMMULITE 2000 / IMMULITE 2500 Probe Wash Module

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 18, 2022

ADVIA Centaur HIV Ag/Ab Combo Quality Control Material (CHIV QC)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 16, 2022

ADVIA Centaur T3 Diluent

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 16, 2022

ADVIA Centaur Multi-Diluent 15 Ready Pack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 16, 2022

ADVIA 560 Lyse

Manufacturer:

DIATRON MI PLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 13, 2022

ADVIA 560 5P Diff

Manufacturer:

DIATRON MI PLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 13, 2022

DIMENSION Lipase Calibrator (LIPL CAL)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 12, 2022

CardioPhase hsCRP

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 12, 2022

ADVIA Chemistry Complement C3 (C3) Reagents

Manufacturer:

RANDOX LABORATORIES LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 11, 2022

ADVIA 560 Control

Manufacturer:

R&D SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 11, 2022

IMMULITE/IMMULITE 1000 Growth Hormone (hGH)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 10, 2022

ADVIA 560 Hematology System

Manufacturer:

DIATRON MI PLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 27, 2022

IMMULITE/IMMULITE 1000 AFP

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 27, 2022

DCA System Microalbumin/Creatinine Reagent Kit

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (MISHAWAKA)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 27, 2022

ADVIA Chemistry ISE Buffer

Manufacturer:

JEOL LTD .

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 24, 2022

IMMULITE Probe Cleaning Kit

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 24, 2022

IMMULITE/IMMULITE 1000 CEA

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 23, 2022

ADVIA 360 Cleaner

Manufacturer:

DIATRON MI PLC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 23, 2022

IMMULITE/IMMULITE 1000 ACTH

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 23, 2022

IMMULITE 2000 Systems Ferritin

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 19, 2022

IMMULITE/IMMULITE 1000 Ferritin

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 19, 2022

IMMULITE/IMMULITE 1000 Insulin

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 19, 2022

IMMULITE HCG Sample Diluent

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 14, 2022

CLINITEK ATLAS Positive Control Strips

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS, INC. (MISHAWAKA)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 14, 2022

ADVIA Centaur ELF Quality Controls (QC) Material

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 14, 2022

CLINITEK ATLAS Negative Control Strips

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS, INC. (MISHAWAKA)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 14, 2022

ADVIA Chemistry ISE Urine Standard Set.

Manufacturer:

JEOL LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 13, 2022

SENTINEL Clin Chem Cal.

Manufacturer:

SENTINEL CH. S.P.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 13, 2022

IMMULITE 1000 Beta-2-Microglobulin

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 13, 2022

ADVIA Centaur Free PSA (fPSA) Calibrator

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 13, 2022

ADVIA Centaur Insulin Diluent (IRI DIL)

Manufacturer:

MINARIS MEDICAL CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 12, 2022

ADVIA Centaur T3/T4/VB12 Ancillary Reagent

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 11, 2022

ADVIA Centaur Multi-Diluent 13

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 11, 2022

ADVIA Chemistry ToxAmmonia Calibrators (ToxAmmonia CAL)

Manufacturer:

MICROGENICS CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 11, 2022

Atellica IM Total Triiodothyronine Diluent (T3 DIL)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 11, 2022

ADVIA Centaur Rubella G II (RbGII)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 11, 2022

ADVIA Chemistry Immunoglobulin M_2 Reagents (IGM_2)

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 8, 2022

ADVIA Chemistry Direct Bilirubin_2 (DBIL_2) Reagents

Manufacturer:

FUJIFILM WAKO PURE CHEMICAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 8, 2022

ADVIA Centaur Calibrator O

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 8, 2022

ADVIA Chemistry Lactate Dehydrogenase L-P Reagents (LDLP)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2022

CLINITEK Novus 10 Urinalysis Cassette

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS, INC. (MISHAWAKA)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 4, 2022

ADVIA Chemistry Anti-Streptolysin-O_2 Reagents (ASO_2)

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 4, 2022

IMMULITE/IMMULITE 1000 Turbo NT-proBNP

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 4, 2022

SENTINEL DIAGNOSTICS RF Latex Autom NG

Manufacturer:

SENTINEL CH SPA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 4, 2022

ADVIA Chemistry Total Protein_2 (Urine) Reagents (UPRO_2)

Manufacturer:

FISCHER DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 2, 2022

DIMENSION Hemoglobin A1c Kit

Manufacturer:

ROCHE DIAGNOSTIC DEUTSCHLAND GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 31, 2022

ADVIA Chemistry Microalbumin_2 Calibrators (µALB_2 CAL)

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 31, 2022

ADVIA Centaur Free PSA (fPSA)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 31, 2022

SENTINEL Lp(a) Ultra

Manufacturer:

SENTINEL CH. SPA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 30, 2022

ADVIA Centaur Rubella G (Rub G)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 30, 2022

Atellica IM T3/T4/VB12 Ancillary Reagent

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 29, 2022

Atellica CH HDL Cholesterol Calibrator (HDLC CAL)

Manufacturer:

SEKISUI MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 24, 2022

Atellica IM Thyroid Stimulating Hormone 3-Ultra (TSH3UL)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 24, 2022

CLINITEK Novus Rinse Additive

Manufacturer:

FISCHER DIAGNOSTICS

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 23, 2022

ADVIA Centaur TIMP-1

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 21, 2022

Dimension Ferritin Flex (FERR)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 14, 2022

Dimension LOCI Cardiac Troponin I Flex reagent cartridge (TNI)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 14, 2022

Atellica IM Toxoplasma IgM (Toxo M)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 14, 2022

ADVIA Chemistry Enzymatic Hemoglobin A1c Calibrators

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 9, 2022

ADVIA Chemistry Microalbumin_2 Reagents

Manufacturer:

RANDOX LABORATORIES LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 8, 2022

Atellica IM Toxoplasma IgM Quality Control (Toxo M QC)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 8, 2022

ADVIA Chemistry Triglycerides_2 (TRIG_2) Reagent

Manufacturer:

RANDOX LABORATORIES, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 8, 2022

ADVIA Chemistry TBIL_2-Total Bilirubin 2 Reagents

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 8, 2022

ADVIA Chemistry Special Chemistry Calibrator (SPCL CHEM CAL )

Manufacturer:

RANDOX LABORATORIES LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 8, 2022

ADVIA Chemistry LDL Cholesterol Direct (DLDL) Reagents

Manufacturer:

RANDOX LABORATORIES LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 7, 2022

ADVIA Chemistry Iron_2 (IRON_2) Reagents

Manufacturer:

RANDOX LABORATORIES, LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 7, 2022

ADVIA Chemistry Pancreatic Amylase (PAMY) Reagents

Manufacturer:

RANDOX LABORATORIES LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 1, 2022

Advia Centaur Vitamin D Total (VitD)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 25, 2022

IMMULITE1000 Rubella IgM

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 25, 2022

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

Manufacturer:

DASH INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 25, 2022

Atellica IM Syphilis (Syph)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 22, 2022

Atellica IM Troponin I Ultra

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 22, 2022

IMMULITE Thyroglobulin Control Module

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 18, 2022

Atellica IM Toxoplasma IgG (Toxo G)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 18, 2022

Atellica IM High-Sensitivity Troponin I

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 18, 2022

Atellica IM Prolactin (PRL).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 11, 2022

Atellica IM Prostate-Specific Antigen (PSA).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 4, 2022

Atellica IM Rubella IgM Quality Control (Rub M QC).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 4, 2022

Atellica IM Homocysteine Calibrator (HCY CAL)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 31, 2021

Atellica IM Rubella IgG Quality Control (Rub G QC).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 24, 2021

Atellica IM Anti-Hepatitis B e Antigen (aHBe).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 23, 2021

Atellica IM Anti-Hepatitis B core Total Quality Control (HBcT QC)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 23, 2021

Atellica IM Hepatitis B e Antigen (HbeAg).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 23, 2021

Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 23, 2021

Atellica IM Follicle Stimulating Hormone (FSH)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 20, 2021

Atellica IM Probe Wash (PW3).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 17, 2021

ADVIA Centaur CMV IgG Ready Pack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 14, 2021

ADVIA Centaur CMV IgG Quality Control (CMV IgG QC)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 14, 2021

ADVIA 120/ADVIA 2120/ADVIA 2120i TESTPOINT Control.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 10, 2021

ADVIA Chemistry Enzymatic Creatinine_2 Reagents

Manufacturer:

SEKISUI DIAGNOSTICS P.E.I. INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 10, 2021

Atellica IM Free Prostate-Specific Antigen (fPSA).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 7, 2021

ADVIA Chemistry C-Reactive Protein_2 Reagents.

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 7, 2021

Atellica IM Complexed Prostate-Specific Antigen (cPSA).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 1, 2021

Atellica CH C-Reactive Protein_2 (CRP_2).

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 29, 2021

ADVIA Chemistry Magnesium Reagents.

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 27, 2021

ADVIA Chemistry Total Protein_2 (Urine) Reagents.

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 27, 2021

DIMENSION VISTA / DIMENSION EXL™ SARS-CoV-2 IgG Calibrator

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 22, 2021

Atellica IM Hepatitis B Core Antigen (aHBcM).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 22, 2021

Atellica IM Calibrator Q (CAL Q).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 10, 2021

Atellica IM Calibrator A (CAL A)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 7, 2021

Atellica IM Anti-Hepatitis B e Antigen Quality Control (aHBe QC)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 7, 2021

Atellica IM CA 125II (CA 125II)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 2, 2021

Atellica IM Calibrator D (CAL D).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 1, 2021

Atellica IM CA 15-3 Calibrator (CA 15-3 CAL).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 1, 2021

Atellica IM Anti-Thyroid Peroxidase (aTPO)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2021

Atellica IM CA 15-3

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 25, 2021

Atellica IM Hepatitis B Core Antigen Quality Control (aHBcM QC).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2021

ADVIA 120/ADVIA 2120/ADVIA 2120i CSF Reagent.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 24, 2021

Atellica IM Anti-Thyroid Peroxidase Quality Control (aTPO QC)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 24, 2021

Atellica IM Ancillary Probe Wash 1 (APW1)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 24, 2021

Atellica IM Alpha Fetoprotein (AFP).

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 Quality Control (aHAVM QC).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 18, 2021

Atellica CH Wash.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 11, 2021

ATELLICA ® IM Anti-Thyroglobulin (aTgII) Ready Pack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 25, 2021

Atellica CH Special Chemistry Calibrator (SPCL CHEM CAL).

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 21, 2021

ADVIA Chemistry CK_L Creatine Kinase Assay.

Manufacturer:

RANDOX LABORATORIES LTD.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 16, 2021

Atellica CH Urine Total Protein Calibrator (UPro CAL).

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 16, 2021

Atellica CH Total Protein_2 (Urine) (UPro).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 15, 2021

Atellica CH Triglycerides (concentrated) (Trig).

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 15, 2021

Atellica CH Total Bilirubin_2 (TBil_2).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 10, 2021

Atellica IM Acid/Base.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 8, 2021

Atellica CH Microalbumin_2 Calibrator (µALB_2 CAL).

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 2, 2021

Atellica CH Reagent Probe Cleaner 2 (RPC2).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 30, 2021

Atellica CH Reagent Probe Cleaner 1 (RPC1).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 30, 2021

Atellica CH Rheumatoid Factor (RF).

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 30, 2021

Atellica CH Lipase (Lip).

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 21, 2021

DIMENSION Mass Creatine Kinase MB Isoenzyme Flex Reagent Cartridge.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 14, 2021

Atellica CH Lactate (Lac).

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 10, 2021

Atellica CH Inorganic Phosphorus (IP).

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 5, 2021

Atellica CH ENZ 3 Calibrator (ENZ 3 CAL).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 2, 2021

Atellica CH Lamp Coolant (LC).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 30, 2021

DIMENSION RCRP Flex Reagent Cartridge.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2021

Atellica CH Cystatin C_2 (CYSC_2).

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2021

DIMENSION CTNI Flex Reagent Cartridge.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 27, 2021

Atellica CH Glucose Hexokinase_3 (GluH_3).

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 19, 2021

Atellica CH Creatinine_2 (Crea_2)

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 14, 2021

Atellica IM CMV IgG Ready Pack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 7, 2021

Atellica CH Tacrolimus (TACR)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 28, 2021

Atellica CH Creatine Kinase (CK_L).

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 22, 2021

Atellica CH Cleaner

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 16, 2021

Atellica CH Diluent.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 16, 2021

Atellica CH Conditioner.

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 16, 2021

ADVIA Centaur CA 19-9 Ready Pack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 11, 2021

Dimension Vista /Dimension EXL™ COV2T/CV2T Pos/Neg Control

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 10, 2021

Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP)

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 3, 2021

Atellica CH Calcium (Ca).

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 28, 2021

Atellica CH Check Reagent (CHK).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 20, 2021

ADVIA Centaur HBcT Ready Pack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 17, 2021

Atellica CH Albumin (Alb)

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 11, 2021

ADVIA Chemistry AMM Ammonia Reagents.

Manufacturer:

RANDOX LABORATORIES LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 5, 2021

Atellica CH Ammonia (Amm).

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 5, 2021

Atellica CH A-LYTE IMT Standard B + Salt Bridge

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 19, 2021

ADVIA Centaur SYPH QC

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 16, 2021

ADVIA Centaur SYPH Ready Pack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 16, 2021

ADVIA Centaur PSA Prostate Specific Antigen Ready Pack

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 13, 2021

DIMENSION EXL LOCI Module Flex Reagent Cartridge TNI

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 18, 2020

IMMULITE 2000 HCG Sample Diluent

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 7, 2020

Atellica Direct Load

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 11, 2020

Atellica Sample Handler Prime

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 8, 2020

Atellica IM Rubella G II

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 8, 2020

Atellica IM Rubella G II Quality Control

Manufacturer:

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 8, 2020

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

Last updated: December 2025