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U.S. Department of Health and Human Services

Product Classification
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Device human immunodeficiency virus (hiv) viral load monitoring test
Regulation Description Human immunodeficiency virus (HIV) viral load monitoring test.
Definition A human immunodeficiency virus (HIV) viral load monitoring test is an in vitro diagnostic prescription device for the quantitation of the amount of HIV ribonucleic acid (RNA) in human body fluids
Physical State Automated sample purification, automated amplification, automated reader, swab, lancet, capillary, needle
Technical Method PCR, nucleic acid amplification, quantitation
Target Area Whole blood, plasma, serum, oral fluid, capillary blood, venous blood
Regulation Medical Specialty Microbiology
Review Panel Clinical Chemistry
Product CodeQUM
Premarket Review CBER Division (CBER)
Submission Type 510(k)
Regulation Number 866.3958
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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