Elecsys HTLV-I/II

STN: 125792/0 Proper Name: Elecsys HTLV-I/II Tradename: Elecsys HTLV-I/II Manufacturer: Roche Diagnostics Indication: Elecsys HTLV-I/II is an in vitro immunoassay for the qualitative detection of antibodies to HTLV-I and HTLV-II in human serum and plasma. Elecsys HTLV-I/II is intended to screen individual human donors, including volunteer donors of whole blood and blood components. The assay is also intended to be used to screen organ, tissue and cell donors, when donor samples are obtained while the donor's heart is still beating and in testing serum specimens to screen cadaveric donors when specimens are obtained after the donor’s heart has stopped beating. It is not intended for use on cord blood specimens. The electrochemiluminescence immunoassay “ECLIA” is intended for use with cobas pro serology solution equipped with cobas e 801 analytical unit. Product Information Package Insert - Elecsys HTLV-I/II Package Insert - PreciControl HTLV Package Insert - PreciControl Release HTLV Supporting Documents October 29, 2025 Approval Letter - Elecsys HTLV-I/II October 17, 2023 Approval Letter - Elecsys HTLV-I/II October 16, 2023 Summary Basis for Regulatory Action - Elecsys HTLV-I/II