Device typeMultiple blood-borne virus antigen/antibody IVD, control: A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of antigens and/or antibodies from one or multiple blood-borne viruses, in a clinical specimen. Viruses intended to be detected may include (but are not limited to) human immunodeficiency virus 1 and 2 (HIV1 and HIV2), Hepatitis B virus, Hepatitis C virus and human T-cell lymphotrophic virus 1 and/or 2 (HTLV1 and/or HTLV2).
FDA categoryKit,test(donors),for bloodborne pathogen
Device ID00847661002574
Catalog number00112
Single useYes
MRI safetyLabeling does not contain MRI Safety Information