Device Dossier

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 Dossier for Elecsys HTLV I/II (*E170, cobas e 411/601/602) - Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit,…

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-1/11 in human serum and plasma

TGA Public Summary