Elecsys HIV Duo
PMA: BP190403
Proper Name: None
Tradename: Elecsys HIV Duo
Manufacturer: Roche Diagnostics
Indication:
- The Elecsys HIV Duo is an immunoassay intended for the in vitro simultaneous qualitative detection and differentiation of HIV-1 p24 antigen and antibodies to HIV, HIV-1 (groups M and O) and HIV-2, in human serum and plasma.
- The Elecsys HIV Duo assay is intended to be used as an aid in the diagnosis of HIV-1 and/or HIV-2 infection, including acute or primary HIV-1 infection.
- The assay may also be used as an aid in the diagnosis of HIV-1/HIV-2 infection in subjects greater than 2 years of age and in pregnant women.
- Elecsys HIV Duo is an electrochemiluminescence immunoassay “ECLIA” intended for use on the cobas e 801 immunoassay analyzer