Device typeHIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test: A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses and may be available [non-prescription] over-the-counter (OTC) for self-testing by a layperson in the home or similar environment.
FDA categoryMonitor,Test,Hiv-1
Device ID00608337000016
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information