Proper Name: Multiplex HIV, HCV, and NBV nucleic acid test for use on the cobas 6800/8800 Systems
Tradename: cobas MPX
Manufacturer: Roche Molecular Systems, Inc.
- Qualitative in vitro nucleic acid screening test for the direct detection of HIV-1 Group M RNA, HIV-1 Group O RNA, HIV-2 RNA, HCV RNA, HBV DNA in human plasma and serum.
- February 25, 2021 Approval Letter - cobas MPX
- January 17, 2020 Approval Letter - cobas MPX Test
- September 21, 2017 Approval Letter - cobas MPX Test
- October 20, 2016 Approval Letter cobas MPX Test
- Summary Basis for Regulatory Action - Cobas MPX Test