Geenius HIV 1/2 Supplemental Assay (BL 125670)

STN: 125670
Proper Name: Human Immunodeficiency Virus Types 1 and 2 (Recombinant and Synthetic Peptides)
Tradename: Geenius HIV 1/2 Supplemental Assay
Manufacturer: Bio-Rad Laboratories, Inc.
Indication:

• The Geenius HIV 1/2 Supplemental Assay 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 serum, or plasma samples, lithium heparin, sodium citrate, and CPD) from blood donors.
• The Geenius HIV 1/2 Supplemental Assay is intended for use as an additional, more specific test for human serum and plasma samples with repeatedly reactive results by an FDA licensed blood donor screening test for antibodies to HIV‑1/HIV‑2.The results of the Geenius HIV 1/2 Supplemental Assay are read and interpreted only with the Geenius. Reader with dedicated software.

Product Information

• Package Insert - Geenius HIV 1/2 Supplemental Assay

Supporting Documents

• August 26, 2019 Summary Basis for Regulatory Action - Geenius HIV 1/2  Supplemental Assay
• August 26, 2019 Approval Letter - Geenius HIV 1/2 Supplemental Assay