Device Category Dossier

Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, chemiluminescent immunoassay

Device Category Dossier for Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, chemiluminescent immunoassay. Australian ARTG…

Device: Alinity s HTLV I/II Assay - Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, chemiluminescent immunoassay
Device: Elecsys HTLV I/II (*E170, cobas e 411/601/602) - Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, chemiluminescent immunoassay
Device: Elecsys HTLV-I/II (cobas e 801) - Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, chemiluminescent immunoassay
Device: Alinity s HTLV-I/II Assay - Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, chemiluminescent immunoassay
Device: Alinity i rHTLV I/II - Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, chemiluminescent immunoassay
Device: LIAISON® XL MUREX recHTLV-I/II - Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, chemiluminescent immunoassay
Device: ARCHITECT rHTLV-I/II assay - Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, chemiluminescent immunoassay

Chemiluminescent microparticle immunoassays (CMIA) detect antibodies to human T-lymphotropic virus Type I and Type II in human serum and plasma through immunoassay methodology. These assays are used for qualitative detection of anti-HTLV I/HTLV II antibodies in clinical specimens, including cadaveric blood collected up to 24 hours postmortem.