Ortho-Clinical VITROS Immunodiagnostic Products Anti-HTLV I/II Assay - HSA Registration DE0507608
Access comprehensive regulatory information for Ortho-Clinical VITROS Immunodiagnostic Products Anti-HTLV I/II Assay in the Singapore medical device market through Pure Global AI's free database. This CLASS D IVD medical device is registered under HSA registration number DE0507608 and owned by Ortho-Clinical Diagnostics. The device was registered on December 15, 2022.
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“For the in vitro qualitative detection of antibodies to human T-cell lymphotropic virus Types I and/or II, (HTLV-I and HTLV-II) in human serum and plasma (heparin, EDTA and citrate) in adults, pregnant women, adolescents and children, using the automated VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems. The results of the VITROS Anti-HTLV I/II test, in conjunction with other serological evidence and clinical information, may be used as an aid in the clinical diagnosis of HTLV infection. It may also be used as a screening test to prevent transmission of HTLV to recipients of blood, blood components, cells, tissue and organs. It is also intended for use to screen organ donors when specimens are obtained while the donor’s heart is still beating”.