Product Classification

• Device: point of care hiv nat diagnostic and/or supplemental test
• Regulation Description: Human immunodeficiency virus (HIV) nucleic acid (NAT) diagnostic and/or supplemental test.
• Definition: Human immunodeficiency virus (HIV) Point of Care nucleic acid diagnostic and supplemental tests are prescription devices for the qualitative detection of HIV nucleic acid in human body fluids or tissues.
• Physical State: Lateral flow, membrane, manual, automated reader, swab, lancet, capillary, NAT, automated instrument
• Technical Method: PCR, amplification, extraction, buffers, purification, nucleic acid, manual, automated
• Target Area: Whole blood, plasma, serum, oral fluid, capillary blood, venous blood
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: QSV
• Premarket Review: Center for Biologics Evaluation & Research (CBER)
• Submission Type: 510(k)
• Regulation Number: 866.3957
• Device Class: 2
• 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