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ROCHE INDONESIA

Authorized Representative in Indonesia

Gedung AIA Central Lantai 36 Jl. Jend. Sudirman KAV. 48A RT/RW 003/004 Kelurahan Karet Semanggi
164 Products Represented
23 Manufacturers
Total Products
164
Manufacturers
23
Product Classes
3
Risk Classes
4
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
37 products
22.6%
Kelas Resiko : B
89 products
54.3%
Kelas Resiko : C
34 products
20.7%
Kelas Resiko : D
4 products
2.4%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (164)
Complete portfolio registered with BPOM

Elecsys Anti-SARS-CoV-2 cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2025

PreciControl Maternal Care

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 23, 2025

COAGUCHEK aPTT Test

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 16, 2024

ROCHE TROP T Sensitive, Troponin T

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 13, 2024

COBAS BM - Lactate

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 13, 2024

ultraView Universal Alkaline Phosphatase Red Detection Kit

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 20, 2024

COBAS Buffer Negative Control Kit for use on the cobas 6800/8800 Systems

Manufacturer:

ROCHE MOLECULAR SYSTEMS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 12, 2024

COBAS omni Wash Reagent

Manufacturer:

ROCHE MOLECULAR SYSTEMS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 11, 2024

COBAS omni Specimen Diluent

Manufacturer:

ROCHE MOLECULAR SYSTEMS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 31, 2024

COBAS omni Lysis Reagent

Manufacturer:

ROCHE MOLECULAR SYSTEMS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 31, 2024

Elecsys T3

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 14, 2024

ROCHE Cardiac Control CK-MB cobas h 232

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 3, 2024

COBAS CRP Test cobas b 101

Manufacturer:

PHC CORPORATION IN VITRO DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 3, 2024

ROCHE CARDIAC Control D-Dimer cobas h 232

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 3, 2024

Elecsys FSH

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 19, 2024

Elecsys Tg II

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 19, 2024

Elecsys FT3 III

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 14, 2024

Elecsys T4

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 9, 2024

Elecsys β-CrossLaps/Serum

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 5, 2024

Elecsys Myoglobin

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 5, 2024

ELECSYS HBsAg Confirmatory Test

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 4, 2024

Elecsys Vitamin B12 II

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 3, 2024

Elecsys Total PSA

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 11, 2024

CONFIRM anti-Tyrosinase (T311) Mouse Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 6, 2024

Elecsys LH

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 3, 2024

Elecsys CEA

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 14, 2024

CONFIRM Negative Control Rabbit Ig

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 3, 2024

CalSet Total-Tau

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 29, 2024

ROCHE Cardiac Control Myoglobin cobas h 232

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 21, 2024

Elecsys Insulin

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 5, 2024

Elecsys Estradiol III

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 4, 2024

LightCycler PRO 384 System

Manufacturer:

ROCHE DIAGNOSTICS INTERNATIONAL LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 28, 2024

LightCycler PRO 96 System

Manufacturer:

ROCHE DIAGNOSTICS INTERNATIONAL LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 28, 2024

Elecsys C-Peptide

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 29, 2023

Elecsys Ferritin

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 29, 2023

ALTL

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2023

ASO

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 8, 2023

Elecsys Anti-Tg

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2023

Elecsys proBNP II

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2023

Elecsys Prolactin II

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2023

COBAS BNZ2

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 2, 2023

VENTANA Antibody Diluent with Casein

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 17, 2023

S100 CalSet

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 7, 2023

COBAS BILD2 Bilirubin Direct Gen.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 23, 2023

Ultra View Silver Wash II

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 23, 2023

ULTRA Cell Conditioning Solution (ULTRA CC1)

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 22, 2023

Cell Conditioning Solution (CC1)

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 22, 2023

Cobas PCR Media Uni Swab Sample Kit

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 21, 2023

Cobas® Omni Utility Channel Reagent Kit

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 20, 2023

COBAS® Sample Prep Buffer

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 18, 2023

Elecsys IGFBP-3

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 23, 2023

COBAS LAMB2

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 10, 2023

Cobas® 4800 System Internal Control Kit 1

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 28, 2023

CalSet FT4 IV

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 20, 2023

BENCHMARK ULTRA and Accessories

Manufacturer:

VENTANA MEDICAL SYSTEMS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 24, 2023

Elecsys HSV-2 IgG cobas and analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 10, 2023

Elecsys Anti-Tg

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 23, 2023

VENTANA CONFIRM anti-CD68 (KP-1) Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 17, 2023

VENTANA anti-Helicobacter pylori (SP48) Rabbit Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 17, 2023

VENTANA CONFIRM anti-Lambda Rabbit Polyclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 15, 2023

Cell Wash Solution I / NaOH-D

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 13, 2023

VENTANA CONFIRM anti-Melanosome (HMB45) Mouse Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 13, 2023

VENTANA anti-MUC1 (H23) Mouse Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 13, 2023

PreClean II M

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 13, 2023

CleanCell M

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 13, 2023

VENTANA CONFIRM anti-MART-1/melan A (A103) Mouse Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 13, 2023

ProCell II M

Manufacturer:

ROCHE DIAGNOSTICS (SUZHOU) LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 9, 2023

VENTANA anti-Chromogranin A (LK2H10) Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 8, 2023

COBAS FT3 III CalSet Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 5, 2022

COBAS Lipid Control

Manufacturer:

CLINIQA CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 25, 2022

VENTANA CONFIRM anti-CD23 (SP23) Rabbit Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 25, 2022

VENTANA anti-Cyclin D1 (SP4-R) Rabbit Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 25, 2022

Elecsys CMV IgG cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 16, 2022

MagNA Pure 24 Total NA Isolation Kit

Manufacturer:

ROCHE DIAGNOSTICS GMBH. CENTRALISED AND POINT OF CARE SOLUTIONS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 16, 2022

Elecsys CMV IgG Avidity cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 14, 2022

VENTANA CONFIRM anti-CD79a (SP18) Rabbit Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 7, 2022

VENTANA anti-E-cadherin (36) Mouse Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 7, 2022

VENTANA anti-p63 (4A4) Mouse Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 3, 2022

VENTANA Confirm anti-Total c-MET (SP44) Rabbit Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 31, 2022

VENTANA CONFIRM anti-CD56 (123C3) Mouse Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2022

VENTANA CONFIRM anti-LM02 (1A9-1) Mouse Monoclonal Primary Antibody

Manufacturer:

VENTANA MEDICAL SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2022

COBAS Elecsys IGF-1 Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2022

MAGNA Pure 24 Instrument and Accessories

Manufacturer:

ROCHE DIAGNOSTICS INTERNATIONAL LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 22, 2022

COBAS® Buffer Negative Control Kit

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 29, 2022

MagNA Pure 24 Instrument and Accessories

Manufacturer:

ROCHE DIAGNOSTICS INTERNATIONAL LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 29, 2022

COBAS ControlSet sTfR II Roche systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2022

MagNA Pure Bacterial Lysis Buffer

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2022

COBAS Calibrator sTfR II Roche systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2022

ACTH CalSet cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2022

MagNA Pure 96 DNA and Viral NA Large Volume Kit

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 7, 2022

AFP CalSet II cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 6, 2022

CA 72-4 CalSet cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 5, 2022

Elecsys HIV Duo cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 27, 2022

Elecsys AFP cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 27, 2022

Elecsys ACTH cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 23, 2022

Elecsys Syphilis cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 23, 2022

MagNA Pure External Lysis Buffer

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 21, 2022

MagNA Pure 24 Total NA Isolation Kit

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 17, 2022

MagNA Pure 96 DNA and Viral NA Small Volume Kit

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 3, 2022

COBAS S3 Fluid Pack A

Manufacturer:

ROCHE DIAGNOSTICS INTERNATIONAL LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 25, 2022

Cobas HBV/HCV/HIV-1 Control Kit

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 12, 2022

Cobas HIV-1/HIV-2 Qualitative Control Kit

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 24, 2022

ACCU-CHEK Performa Blood Glucose Meter

Manufacturer:

SANMINA CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 25, 2022

ACCU-CHEK Instant S Blood Glucose Meter

Manufacturer:

ALTEK BIOTECHNOLOGY CORPORATION/ALTEK ( KUNSHAN) CORP.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 25, 2022

ACCU-CHEK Instant Wireless Blood Glucose Meter

Manufacturer:

ALTEK BIOTECHNOLOGY CORPORATION/ALTEK (KUNSHAN) CORP., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 24, 2022

Digoxin CalSet Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 22, 2022

Elecsys ProGRP cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 22, 2022

CalSet Troponin I cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 8, 2022

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

Manufacturer:

ROCHE DIABETES CARE, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 3, 2022

Elecsys HBsAg II Auto Confirm cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 26, 2022

PTH (1-84) CalSet Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2022

PreciControl HBsAg Auto Confirm cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 10, 2022

Cobas CT/NG Positive Control Kit

Manufacturer:

ROCHE MOLECULAR SYSTEMS INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 15, 2021

cobas HPV Positive Control for use on the cobas 6800/8800 Systems

Manufacturer:

ROCHE MOLECULAR SYSTEMS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 23, 2021

Elecsys Testosterone II cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 15, 2021

Elecsys PTH (1-84) cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 15, 2021

SD BIOSENSOR SARS-CoV-2 Antigen Control

Manufacturer:

SD BIOSENSOR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 9, 2021

Accu-Chek Guide Set Wireless Blood Glucose Meter and Lancing Device

Manufacturer:

SANMINA-SCI INDIA PVT LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 1, 2021

COBAS p501 and Accessories

Manufacturer:

ROCHE DIAGNOSTICS INTERNATIONAL LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 1, 2021

Elecsys SARS-CoV-2 Antigen cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 14, 2021

COBAS CalSet Anti-SARS-CoV-2 S cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 13, 2021

COBAS PreciControl Anti-SARS-CoV-2 S cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 13, 2021

COBAS 4800 System Sample Preparation Kit 2 (c4800 SMPL PREP 2)

Manufacturer:

ROCHE MOLECULAR SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 21, 2021

Elecsys Anti-SARS-CoV-2 S cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 14, 2021

ACCUTREND Glucose

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 13, 2021

SARS-CoV-2 Extraction Solution C cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 13, 2021

Elecsys S100 cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 3, 2021

Elecsys IL-6 cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 3, 2021

SARS-CoV-2 Extraction Solution cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 18, 2021

COBAS Ferritin CalSet Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 15, 2021

COBAS CA 72-4 CalSet Elecsys and Cobas e Analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 23, 2020

COMBUR 3 Test (pH, PRO, GLU)

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 14, 2020

Accu-Chek Guide Link Kit

Manufacturer:

SANMINA CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 3, 2020

ACCU-CHEK Performance Set

Manufacturer:

SANMINA CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 9, 2019

BARB Abuscreen Online Barbiturates Cobas Integra

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 30, 2019

COBAS ISE Standard High Roche/Hitachi cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 11, 2019

COBAS ISE Standard Low Roche/Hitachi cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 11, 2019

COBAS INSTC Instrument Check cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 11, 2019

COBAS ELECSYS HbsAg II quant II Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 7, 2019

COBAS CRPLX cobas c 111 C-reactive Protein (Latex)

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 5, 2019

COBAS HCYS Homocysteine Enzymatic Assay cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 5, 2019

COBAS ALTL COBAS c 111

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 28, 2019

COBAS GLU Roche/Hitachi Glucose GOD-PAP

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 28, 2019

COBAS STFR Tina-quant Soluble Transferrin Receptor cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 12, 2019

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

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 12, 2019

COBAS SI2 Serum Index Gen.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 29, 2019

COBAS PREA Prealbumin cobas c systems

Manufacturer:

ROCHE DIAGNOSICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 29, 2019

COBAS NH3L Ammonia cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 29, 2019

COBAS START Antigen Excess Reagent cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 29, 2019

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

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 27, 2019

COBAS MYO2 Tina-quant Myoglobin Gen.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 24, 2019

COBAS B2MG Tina-quant β 2-Microglobulin cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 24, 2019

COBAS CERU Ceruloplasmin cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 23, 2019

COBAS PreciControl Thyro Sensitive Elecsys and cobas e analyzer

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 23, 2019

COBAS ALTPM Alanine Aminotransferase PyP cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 23, 2019

COBAS LACT2 Lactate Gen.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 23, 2019

COBAS AAT2 Tina-quant α 1 - Antitrypsin ver.2 cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2019

COBAS ASTPM Aspartate Aminotransferase PyP Cobas c Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2019

COBAS ASLOT Tina-quant Antistreptolysin O cobas C Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 16, 2019

COBAS A1MG2 Tina-quant Alpha 1-Microglobulin Gen.2 Cobas c Systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 15, 2019

COBAS Elecsys AMH Elecsys and Cobas e Aanalyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 15, 2019

COBAS PreciControl AMH Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 13, 2019

COBAS AMH CalSet Elecsys and cobas e analyzers

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 13, 2019

COBAS FRA Fructosamine cobas c systems

Manufacturer:

ROCHE DIAGNOSTICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 10, 2019

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

Last updated: December 2025