FDA Biologics (BLA & Biosimilars)Original article
Geenius HIV 1/2 Supplemental Assay (BL 125670)
BLA FilingGeenius HIV 1/2 Supplemental AssayNeutral
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Summary
Geenius HIV 1/2 Supplemental Assay (BL 125670) is a single-use immunochromatographic assay for confirming and differentiating HIV-1 and HIV-2 antibodies in serum or plasma samples from blood donors.
Outcome Details
Supplemental assay for HIV-1/2 antibody confirmation and differentiation (BL 125670)
Importance:2/10
Sentiment:
0.00
HIV diagnosticsImmunochromatographic assayFDA BLAIn vitro diagnosticBlood screening
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Published by FDA Biologics (BLA & Biosimilars) on July 8, 2026 4:50 PM