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U.S. Department of Health and Human Services

Product Classification
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Device point of care hiv serology diagnostic and/or supplemental test
Regulation Description Human immunodeficiency virus (HIV) serological diagnostic and/or supplemental test.
Definition Human immunodeficiency virus (HIV) Point of Care serological diagnostic and supplemental tests are prescription devices for the qualitative detection of HIV antigen(s) and/or detection of antibodies against HIV in human body fluids or tissues.
Physical State Lateral flow, membrane, manual, automated reader, swab, lancet, capillary
Technical Method Antibody/antigen, elisa, chemiluminescence, manual
Target Area Whole blood, plasma, serum, oral fluid, capillary blood, venous blood
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeQSU
Premarket Review Center for Biologics Evaluation & Research (CBER)
Submission Type 510(k)
Regulation Number 866.3956
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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