Roche Molecular Systems Inc - Manufacturer Profile

Explore comprehensive manufacturer profile for Roche Molecular Systems Inc through Pure Global AI's free Australia TGA ARTG medical device database. This company has manufactured 53 medical devices registered with TGA ARTG across 4 device classes. This manufacturer is based in United States of America. Their registration history spans from Jul 19, 2010 to Dec 20, 2023.

This page provides detailed insights including recent device registrations, risk class distribution (Class IIa: 4, Class IIb: 25, Class I: 8, Class III: 16), and complete regulatory information from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices.

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53 Devices

4 Device Classes

Roche Molecular Systems Inc

Manufacturer • United States of America

53

Total Devices

4

Device Classes

2010

Earliest

2023

Latest

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Recent Device Registrations

Latest 10 TGA ARTG device registrations

cobas HIV-1/HIV-2 Qualitative (cobas 5800/6800/8800) - HIV1/HIV2 nucleic acid IVD, kit, nucleic acid technique (NAT)

ARTG 431351

Sponsor: Roche Diagnostics Australia Pty Limited

cobas HIV-1/HIV-2 Qualitative (cobas 5800/6800/8800) - HIV1/HIV2 nucleic acid IVD, kit, nucleic acid technique (NAT)

Sponsor: Roche Diagnostics Australia Pty Limited

cobas HIV-1 (cobas 5800/6800/8800) - HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT)

Sponsor: Roche Diagnostics Australia Pty Limited

cobas HIV-1 (cobas 5800/6800/8800) - HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT)

ARTG 429994

Sponsor: Roche Diagnostics Australia Pty Limited

cobas DPX - Hepatitis A/Parvovirus B19 virus nucleic acid IVD, kit, nucleic acid technique (NAT)

ARTG 428597

Sponsor: Roche Diagnostics Australia Pty Limited

cobas DPX - Hepatitis A/Parvovirus B19 virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Sponsor: Roche Diagnostics Australia Pty Limited

cobas MPX (cobas 5800/6800/8800) - HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Sponsor: Roche Diagnostics Australia Pty Limited

cobas MPX (cobas 5800/6800/8800) - HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

ARTG 426910

Sponsor: Roche Diagnostics Australia Pty Limited

cobas NHP Negative Control Kit (cobas 5800/6800/8800) - PCR/NAT negative control IVD

ARTG 413915

Sponsor: Roche Diagnostics Australia Pty Limited

cobas NHP Negative Control Kit (cobas 5800/6800/8800) - PCR/NAT negative control IVD

Sponsor: Roche Diagnostics Australia Pty Limited

Risk Class Distribution

Devices by risk class

Class I

8

15.1% of total

Class IIa

4

7.5% of total

Class IIb

25

47.2% of total

Class III

16

30.2% of total