Bio-Rad BioPlex 2200 Syphilis Total & RPR - HSA Registration DE0503681
Access comprehensive regulatory information for Bio-Rad BioPlex 2200 Syphilis Total & RPR 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 DE0503681 and owned by Bio-Rad Laboratories. The device was registered on October 01, 2019.
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The BioPlex 2200 Syphilis Total & RPR kit is a multiplex flow immunoassay intended for the qualitative detection of Total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of non-treponemal reagin antibodies in human serum or plasma. The test system can be used in conjunction with other serological tests and clinical findings to aid in the diagnosis of syphilis infection. The BioPlex 2200 Syphilis Total & RPR kit is also intended for use in screening blood or plasma donors for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum. The BioPlex 2200 Syphilis Total & RPR kit is intended for use with the Bio‑Rad BioPlex 2200 System.