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Geenius HIV 1/2 Supplemental Assay

PMA:  BP140120
Proper Name:  HIV Detection Test
Tradename: Geenius™ HIV 1/2 Supplemental Assay
Manufacturer: Bio-Rad Laboratories, Inc.

  • Is a single-use immunochromatographic assay for the confirmation and differentiation of individual antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1 and HIV-2) in fingerstick whole blood, venous whole blood, serum, or plasma samples (EDTA, heparin, and sodium citrate).
  • Intended for use as an additional, more specific test to confirm the presence of antibodies to HIV-1 and HIV-2 for specimens found to be repeatedly reactive by diagnostic screening procedures. The assay may also be used to confirm the presence of antibodies to HIV-1 and/or HIV-2 in pediatric subjects (i.e., children as young as 2 years of age). 

Approval Date: October 24, 2014

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