STN: BL 125394
Proper Name: Human T-Lymphotropic Virus Types I & II (HTLV-I and HTLV-II/Enzyme Immuno Assay (EIA)/Lysate
Tradename: Avioq HTLV-I/II Microelisa System
Manufacturer: Avioq, Inc.
- The Avioq HTLV I/II assay is a qualitative ELISA for the detection of antibodies to HTLV-I and/or HTLV-II in human serum or plasma from volunteer blood donors, other living donors, and cadaveric specimens on the ORTHO® Summit System (OSS), and for manual use as an aid in clinical diagnosis of HTLV-I or HTLV-II infection and related diseases. It is not intended for use on cord blood specimens.
- February 17, 2023 Approval Letter - Avioq HTLV-I/II Microelisa System
- Supporting Documents older than three years - Avioq HTLV-I/II EIA/Lysate