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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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INSTI™ HIV-1 Antibody Test

Applicant: bioLytical Laboratories Inc.
Product: INSTI HIV-1 Antibody Test
PMA Number: BP090032/0
Indication for Use: For the detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) in human venipuncture whole blood, fingerstick blood, or plasma specimens.
Approval Date: November 29, 2010