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FDA Biologics (BLA & Biosimilars)
Original article

BK261388- INSTI® HIV-1/HIV-2 Antibody Test

RegulatoryINSTI HIV-1/HIV-2 Antibody TestNeutral
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Summary

BK261388 INSTI HIV-1/HIV-2 Antibody Test is a rapid, single-use immunoassay for detecting HIV-1/HIV-2 antibodies in whole blood, fingerstick blood, or plasma specimens.

Importance:2/10
Sentiment:
0.00
diagnosticHIVrapid-testimmunoassayFDA clearance
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Published by FDA Biologics (BLA & Biosimilars) on September 17, 2026 5:04 PM

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