Point Of Care Hiv Nat Diagnostic And/Or Supplemental Test
Medical specialty
Microbiology
Device class
2
Regulation number
866.3957
Review panel
MI
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.