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In this section: Approved Blood Products

Elecsys HIV combi PT

PMA: BP160050
Tradename: Elecsys HIV combi PT
Manufacturer: Roche Diagnostics.
Indications:

Immunoassay for the in vitro qualitative determination of HIV‑1 p24 antigen and antibodies to HIV‑1 (HIV‑1 groups M and O) and HIV‑2 in human serum and plasma. Elecsys HIV combi PT 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.

Approval Date: June 21, 2017

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