PMA: BP140111
Device Generic Name: Human Immunodeficiency Virus (HIV) p24 antigen and antibodies to HIV Type 1 (HIV-1 group M and group O) and/or Type 2
Tradename: BioPlex 2200 HIV Ag-Ab
Manufacturer: Bio-Rad Laboratories
Indications:

• A multiplex flow immunoassay intended for the simultaneous qualitative detection and differentiation of the individual analytes HIV‑1 p24 antigen, HIV‑1 (groups M and O) antibodies, and HIV‑2 antibodies in human serum or plasma (fresh or frozen K2 EDTA, K3 EDTA, lithium heparin, sodium heparin; fresh citrate). This assay is intended as an aid in the diagnosis of infection with HIV‑1 and/or HIV‑2, including acute (primary) HIV‑1 infection. The assay may also be used as an aid in the diagnosis of infection with HIV-1 and/or HIV-2 in pediatric subjects as young as two years of age, and pregnant women. 
  
  Approval Date: July 23, 2015

Product Information

• Package Insert - BioPlex 2200 HIV Ag-Ab Assay
• Package Insert - BioPlex Ag-Ab Control Set
• Package Insert - BioPlex HIV Ag-Ab Calibrator Set

Supporting Documents

• Supporting Documents older than three years - BioPlex 2200 HIV Ag-Ab Assay