STN: 125778
Proper Name: Elecsys HIV Duo
Tradename: Elecsys HIV Duo
Manufacturer: Roche Diagnostics
Indication:

• Elecsys HIV Duo is an in vitro immunoassay for the 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.
• Elecsys HIV Duo is intended to screen individual human donors, including volunteer donors of whole blood, blood components and source plasma.
• The assay is also intended to be used to screen organ, tissue and cell donors, when donor samples are obtained while the donor's heart is still beating.
• It is not intended for use on cord blood specimens.
• The electrochemiluminescence immunoassay “ECLIA” is intended for use with cobas pro serology solution equipped with cobas e 801 analytical unit.

Product Information

• Package Insert - Elecsys HIV Duo
• Package Insert - PreciControl HIV Gen II
• Package Insert - PreciControl HIV. HIV-2+GprO
• Package Insert - PreciControl Release HIV Gen II

Supporting Documents

• June 13, 2023 Approval Letter - Elecsys HIV Duo
• June 12, 2023 Summary Basis for Regulatory Action - Elecsys HIV Duo