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U.S. Department of Health and Human Services

Product Classification
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Device lab-based 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) lab-based 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
Target Area Whole blood, plasma, serum, oral fluid, capillary blood, venous blood
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeQST
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
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