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Manufacturer profile

ROCHE MOLECULAR SYSTEMS INC.

Indonesia flagIndonesia·United States·20 products registered
20
Total Products
20
Product Names
3
Product Classes
4
Risk Classes
Risk classification breakdown

Distribution of products across risk classes

Kelas Resiko : A
4
20.0% of total
Kelas Resiko : B
8
40.0% of total
Kelas Resiko : C
5
25.0% of total
Kelas Resiko : D
3
15.0% of total
Product class portfolio

Products organized by product class

Kelas : 213 Products
COBAS DNA Sample Preparation Kit (DNA SP)Dec 13, 2024
Kelas Resiko : B
COBAS 4800 BRAF V600 Mutation TestDec 12, 2024
Kelas Resiko : C
COBAS omni MGP ReagentNov 1, 2024
Kelas Resiko : B
COBAS omni Specimen DiluentOct 31, 2024
Kelas Resiko : B
COBAS omni Lysis ReagentOct 31, 2024
Kelas Resiko : B

... and 8 more products in this class

Kelas : 14 Products
COBAS Buffer Negative Control Kit for use on the cobas 6800/8800 SystemsNov 12, 2024
Kelas Resiko : A
COBAS omni Wash ReagentNov 11, 2024
Kelas Resiko : A
COBAS 4800 System Wash Buffer KitMay 7, 2024
Kelas Resiko : A
COBAS 4800 System Liquid Cytology Preparation KitMay 3, 2024
Kelas Resiko : A
Kelas : 33 Products
COBAS HBV Quantitative Nucleic Acid Test for Use on The Cobas 4800 SystemJul 27, 2021
Kelas Resiko : D
COBAS HCV Quantitative nucleic acid test for use on the cobas 6800/8800 systemsJan 27, 2021
Kelas Resiko : D
COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0Jul 24, 2020
Kelas Resiko : D
Recent registrations (20 most recent)

Most recently registered products with BPOM

COBAS DNA Sample Preparation Kit (DNA SP)Dec 13, 2024
Class: Kelas : 2
Risk Class: Kelas Resiko : B
COBAS 4800 BRAF V600 Mutation TestDec 12, 2024
Class: Kelas : 2
Risk Class: Kelas Resiko : C
COBAS Buffer Negative Control Kit for use on the cobas 6800/8800 SystemsNov 12, 2024
Class: Kelas : 1
Risk Class: Kelas Resiko : A
COBAS omni Wash ReagentNov 11, 2024
Class: Kelas : 1
Risk Class: Kelas Resiko : A
COBAS omni MGP ReagentNov 1, 2024
Class: Kelas : 2
Risk Class: Kelas Resiko : B
COBAS omni Specimen DiluentOct 31, 2024
Class: Kelas : 2
Risk Class: Kelas Resiko : B
COBAS omni Lysis ReagentOct 31, 2024
Class: Kelas : 2
Risk Class: Kelas Resiko : B
COBAS 4800 System Wash Buffer KitMay 7, 2024
Class: Kelas : 1
Risk Class: Kelas Resiko : A
COBAS 4800 System Liquid Cytology Preparation KitMay 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 KitFeb 1, 2024
Class: Kelas : 2
Risk Class: Kelas Resiko : C
COBAS HBV Quantitative Nucleic Acid Test for Use on The Cobas 4800 SystemJul 27, 2021
Class: Kelas : 3
Risk Class: Kelas Resiko : D
COBAS 4800 System Control Diluent KitMay 24, 2021
Class: Kelas : 2
Risk Class: Kelas Resiko : C
COBAS 4800 CT / NG Controls KitMay 24, 2021
Class: Kelas : 2
Risk Class: Kelas Resiko : C
COBAS 4800 CT / NG Amplification/Detection KitMay 24, 2021
Class: Kelas : 2
Risk Class: Kelas Resiko : C
COBAS HCV Quantitative nucleic acid test for use on the cobas 6800/8800 systemsJan 27, 2021
Class: Kelas : 3
Risk Class: Kelas Resiko : D
COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0Jul 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 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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