Product Classification

• Device: hiv self-tests
• Definition: Human immunodeficiency virus (HIV) self-tests are intended for use by an individual to test themselves for the presence of HIV in body fluids.
• Physical State: Lateral flow, membrane, manual, automated reader, swab, lancet, capillary
• Technical Method: Antibody/antigen, elisa, chemiluminescence, manual, NAT
• Target Area: Whole blood, plasma, serum, oral fluid, capillary blood
• Review Panel: Microbiology
• Product Code: QSS
• Premarket Review: Center for Biologics Evaluation & Research (CBER)
• Submission Type: PMA
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible