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INSTI HIV-1/HIV-2 Antibody Test

Applicant: bioLytical Laboratories Inc.
Product: INSTI HIV-1/HIV-2 Antibody Test
PMA Number: BP090032
Indication for Use:

  • For the detection of antibodies to Human Immunodeficiency Virus Type 1 and/or Type 2 (HIV-1/HIV-2) in human venipuncture whole blood, fingerstick blood, or plasma specimens.

Approval Date: January 28, 2015

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