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FDA-cleared BioPlex assay, 10/17

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October 2017—Bio-Rad Laboratories announced FDA clearance for its BioPlex 2200 ToRC IgM Assay, a fully automated assay for the detection of IgM class antibodies to Toxoplasma gondii, rubella, and cytomegalovirus offered in a multiplexed panel. When used with the BioPlex 2200 System, the BioPlex 2200 ToRC assays, both the IgG and IgM, provide a rapid and comprehensive prenatal testing solution for three of the most clinically significant diseases. Toxoplasma gondii, rubella, and CMV are pathogens commonly associated with congenital diseases and therefore are tested during the first trimester of pregnancy.

Bio-Rad, 510-724-7000

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