STN: BL 125459
Proper Name: HIV-1 Group O and M, HIV-2, HCV and/or HBV (HIV-1/HIV-2/HCV/HBV/Multiplex Discriminatory NAT)
Tradename: cobas TaqScreen MPX Test, version 2.0 for use with the cobas s 201 system
Manufacturer: Roche Molecular Systems, Inc.
Direct detection of Human Immunodeficiency Virus Type 1 (HIV-1) Group M RNA, HIV-1 Group O RNA, Human Immunodeficiency Virus Type 2 (HIV-2) RNA, Hepatitis C Virus (HCV) RNA, and Hepatitis B Virus (HBV) DNA in human plasma.
Simultaneous detection and discrimination of HIV RNA, HCV RNA, and HBV DNA.
- September 21, 2017 Approval Letter - Cobas TaqScreen MPX Test, v2.0 for use on the s 201 system
- December 19, 2014 Approval Letter - cobas TaqScreen MPX Test, version 2.0 for use with the cobas s 201 system
- Summary Basis for Regulatory Action - cobas TaqScreen MPX Test, version 2.0 for use with the cobas s 201 system