Ortho-Clinical VITROS Immunodiagnostics Product Syphilis TPA Assay - HSA Registration DE0504857
Access comprehensive regulatory information for Ortho-Clinical VITROS Immunodiagnostics Product Syphilis TPA Assay in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0504857 and owned by Ortho-Clinical Diagnostics. The device was registered on August 24, 2020.
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For the qualitative determination of total (IgG and IgM) antibodies to Treponema pallidum (TP) specific antigens in human serum and plasma (heparin, EDTA and citrate) using the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems.The presence of antibodies to Treponema pallidum (TP) specific antigens, in conjunction with non-treponemal laboratory tests and clinical findings may aid in the diagnosis of recent, past or treated syphilis infection.