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Roche Molecular Systems Inc

Manufacturer • United States of America · 53 devices on the TGA ARTG · 4 device classes · Jul 19, 2010 – Dec 20, 2023

53
Total Devices
4
Device Classes
2010
Earliest
2023
Latest
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)
Class IIIDec 20, 2023
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)
ARTG 431351
Class IIIDec 20, 2023
Sponsor: Roche Diagnostics Australia Pty Limited
cobas HIV-1 (cobas 5800/6800/8800) - HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT)
Class IIIDec 06, 2023
Sponsor: Roche Diagnostics Australia Pty Limited
cobas HIV-1 (cobas 5800/6800/8800) - HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT)
ARTG 429994
Class IIIDec 06, 2023
Sponsor: Roche Diagnostics Australia Pty Limited
cobas DPX - Hepatitis A/Parvovirus B19 virus nucleic acid IVD, kit, nucleic acid technique (NAT)
ARTG 428597
Class IIINov 24, 2023
Sponsor: Roche Diagnostics Australia Pty Limited
cobas DPX - Hepatitis A/Parvovirus B19 virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Class IIINov 24, 2023
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
Class IIIOct 25, 2023
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)
Class IIIOct 25, 2023
Sponsor: Roche Diagnostics Australia Pty Limited
cobas NHP Negative Control Kit (cobas 5800/6800/8800) - PCR/NAT negative control IVD
ARTG 413915
Class IIIJul 21, 2023
Sponsor: Roche Diagnostics Australia Pty Limited
cobas HBV/HCV/HIV-1 Control Kit (cobas 5800/6800/8800) - HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
ARTG 413911
Class IIIJul 21, 2023
Sponsor: Roche Diagnostics Australia Pty Limited
View All 53 Devices →
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
About this 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 I: 8, Class IIb: 25, Class III: 16, Class IIa: 4), 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.

Free Manufacturer ProfilePowered by Pure Global AI53 Devices4 Device Classes