Manufacturer profile

ROCHE MOLECULAR SYSTEMS INC.

IndonesiaUnited States20 products registered

VerifiedKemenkes (Ministry of Health) · official registry

Total Products

Product Names

Product Classes

Risk Classes

Regulatory footprint

Search ROCHE MOLECULAR SYSTEMS INC. across other regulatory registries

Risk classification breakdown

Distribution of products across risk classes

Kelas Resiko : A420.0% of total

Kelas Resiko : B840.0% of total

Kelas Resiko : C525.0% of total

Kelas Resiko : D315.0% of total

Product class portfolio

Products organized by product class

Kelas : 2

COBAS DNA Sample Preparation Kit (DNA SP), COBAS 4800 BRAF V600 Mutation Test, COBAS omni MGP Reagent, COBAS omni Specimen Diluent, COBAS omni Lysis Reagent ... and 8 more products in this class

13 Products

Kelas : 1

COBAS Buffer Negative Control Kit for use on the cobas 6800/8800 Systems, COBAS omni Wash Reagent, COBAS 4800 System Wash Buffer Kit, COBAS 4800 System Liquid Cytology Preparation Kit

4 Products

Kelas : 3

COBAS HBV Quantitative Nucleic Acid Test for Use on The Cobas 4800 System, COBAS HCV Quantitative nucleic acid test for use on the cobas 6800/8800 systems, COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0

3 Products

Recent registrations (20 most recent)

Most recently registered products with Ministry of Health

COBAS DNA Sample Preparation Kit (DNA SP)

Dec 13, 2024

Class: Kelas : 2
Risk Class: Kelas Resiko : B

COBAS 4800 BRAF V600 Mutation Test

Dec 12, 2024

Class: Kelas : 2
Risk Class: Kelas Resiko : C

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

Nov 12, 2024

Class: Kelas : 1
Risk Class: Kelas Resiko : A

COBAS omni Wash Reagent

Nov 11, 2024

Class: Kelas : 1
Risk Class: Kelas Resiko : A

COBAS omni MGP Reagent

Nov 1, 2024

Class: Kelas : 2
Risk Class: Kelas Resiko : B

COBAS omni Specimen Diluent

Oct 31, 2024

Class: Kelas : 2
Risk Class: Kelas Resiko : B

COBAS omni Lysis Reagent

Oct 31, 2024

Class: Kelas : 2
Risk Class: Kelas Resiko : B

COBAS 4800 System Wash Buffer Kit

May 7, 2024

Class: Kelas : 1
Risk Class: Kelas Resiko : A

COBAS 4800 System Liquid Cytology Preparation Kit

May 3, 2024

Class: Kelas : 1
Risk Class: Kelas Resiko : A

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

Feb 25, 2024

Class: Kelas : 2
Risk Class: Kelas Resiko : B

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

Feb 17, 2024

Class: Kelas : 2
Risk Class: Kelas Resiko : B

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

Feb 13, 2024

Class: Kelas : 2
Risk Class: Kelas Resiko : B

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

Feb 6, 2024

Class: Kelas : 2
Risk Class: Kelas Resiko : B

COBAS 4800 HPV Amplification/Detection Kit

Feb 1, 2024

Class: Kelas : 2
Risk Class: Kelas Resiko : C

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

Jul 27, 2021

Class: Kelas : 3
Risk Class: Kelas Resiko : D

COBAS 4800 System Control Diluent Kit

May 24, 2021

Class: Kelas : 2
Risk Class: Kelas Resiko : C

COBAS 4800 CT / NG Controls Kit

May 24, 2021

Class: Kelas : 2
Risk Class: Kelas Resiko : C

COBAS 4800 CT / NG Amplification/Detection Kit

May 24, 2021

Class: Kelas : 2
Risk Class: Kelas Resiko : C

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

Jan 27, 2021

Class: Kelas : 3
Risk Class: Kelas Resiko : D

COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0

Jul 24, 2020

Class: Kelas : 3
Risk Class: Kelas Resiko : D

About this profile

ROCHE MOLECULAR SYSTEMS INC. from United States is a medical device manufacturer with 20 registered products in the Indonesia Ministry of Health database through Pure Global AI's free platform. The company produces 20 unique product types across 3 product classes.

This page provides comprehensive manufacturer intelligence including complete product portfolio, risk class distribution, and product class analysis. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify manufacturers, analyze portfolios, and discover partnership opportunities efficiently.