Vaccines, Blood & Biologics
-
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
-
Supporting Documents
November 29, 2010 Approval Letter - INSTI HIV-1 Antibody Test Kit Indicated for the detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) in human venipuncture whole blood, fingerstick blood, or plasma specimens. Summary of Safety and Effectiveness Data - INSTI HIV-1 Antibody Test (PDF - 887KB)Kit Controls - INSTI HIV-1 Antibody Test (PDF - 169KB)Customer Letter - INSTI HIV-1 Antibody Test (PDF - 74KB)Subject Information Brochure - INSTI HIV-1 Antibody Test (PDF - 127KB)
-
-
-
