ROCHE MOLECULAR SYSTEMS INC. - Medical Device Manufacturer in Indonesia

ROCHE MOLECULAR SYSTEMS INC. from United States is a medical device manufacturer with 20 registered products in the Indonesia BPOM 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.

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20 Products

3 Classes

🇮🇩

ROCHE MOLECULAR SYSTEMS INC.

United States

20

Total Products

20

Product Names

3

Product Classes

4

Risk Classes

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Risk Classification Breakdown

Distribution of products across risk classes

Kelas Resiko : A

4 products

20.0%

Kelas Resiko : B

8 products

40.0%

Kelas Resiko : C

5 products

25.0%

Kelas Resiko : D

3 products

15.0%

Product Class Portfolio

Products organized by product class

Kelas : 2

13 Products

COBAS DNA Sample Preparation Kit (DNA SP)

Kelas Resiko : B

COBAS 4800 BRAF V600 Mutation Test

Kelas Resiko : C

COBAS omni MGP Reagent

Kelas Resiko : B

COBAS omni Specimen Diluent

Kelas Resiko : B

COBAS omni Lysis Reagent

Kelas Resiko : B

... and 8 more products in this class

Kelas : 1

4 Products

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

Kelas Resiko : A

COBAS omni Wash Reagent

Kelas Resiko : A

COBAS 4800 System Wash Buffer Kit

Kelas Resiko : A

COBAS 4800 System Liquid Cytology Preparation Kit

Kelas Resiko : A

Kelas : 3

3 Products

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

Kelas Resiko : D

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

Kelas Resiko : D

COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0

Kelas Resiko : D

Recent Registrations (20 most recent)

Most recently registered products with BPOM

COBAS DNA Sample Preparation Kit (DNA SP)

Kelas : 2

Kelas Resiko : B

Registration Date:

Dec 13, 2024

COBAS 4800 BRAF V600 Mutation Test

Kelas : 2

Kelas Resiko : C

Registration Date:

Dec 12, 2024

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

Kelas : 1

Kelas Resiko : A

Registration Date:

Nov 12, 2024

COBAS omni Wash Reagent

Kelas : 1

Kelas Resiko : A

Registration Date:

Nov 11, 2024

COBAS omni MGP Reagent

Kelas : 2

Kelas Resiko : B

Registration Date:

Nov 1, 2024

COBAS omni Specimen Diluent

Kelas : 2

Kelas Resiko : B

Registration Date:

Oct 31, 2024

COBAS omni Lysis Reagent

Kelas : 2

Kelas Resiko : B

Registration Date:

Oct 31, 2024

COBAS 4800 System Wash Buffer Kit

Kelas : 1

Kelas Resiko : A

Registration Date:

May 7, 2024

COBAS 4800 System Liquid Cytology Preparation Kit

Kelas : 1

Kelas Resiko : A

Registration Date:

May 3, 2024

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

Kelas : 2

Kelas Resiko : B

Registration Date:

Feb 25, 2024

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

Kelas : 2

Kelas Resiko : B

Registration Date:

Feb 17, 2024

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

Kelas : 2

Kelas Resiko : B

Registration Date:

Feb 13, 2024

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

Kelas : 2

Kelas Resiko : B

Registration Date:

Feb 6, 2024

COBAS 4800 HPV Amplification/Detection Kit

Kelas : 2

Kelas Resiko : C

Registration Date:

Feb 1, 2024

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

Kelas : 3

Kelas Resiko : D

Registration Date:

Jul 27, 2021

COBAS 4800 System Control Diluent Kit

Kelas : 2

Kelas Resiko : C

Registration Date:

May 24, 2021

COBAS 4800 CT / NG Controls Kit

Kelas : 2

Kelas Resiko : C

Registration Date:

May 24, 2021

COBAS 4800 CT / NG Amplification/Detection Kit

Kelas : 2

Kelas Resiko : C

Registration Date:

May 24, 2021

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

Kelas : 3

Kelas Resiko : D

Registration Date:

Jan 27, 2021

COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0

Kelas : 3

Kelas Resiko : D

Registration Date:

Jul 24, 2020