Device Dossier

Elecsys HTLV-I/II (cobas e 801) - Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, chemiluminescent immunoassay

Device Dossier for Elecsys HTLV-I/II (cobas e 801) - Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, chemiluminescent…

Intended purpose

Immunoassay for the in vitro qualitative determination of antibodies to HTLV-I/II in human serum and plasma

Functional description

An electrochemiluminescence immunoassay "ECLIA" intended for use on cobas e immunoassay analysers for the in vitro qualitative determination of antibodies to HTLV-I/II in human serum and plasma

TGA Public Summary