In Brief: Centocor
This article was originally published in The Gray Sheet
Centocor: Gains FDA go-ahead to market two new diagnostic tests: the Captia syphilis-G, a microtiter-based enzyme immunoassay for use in blood banks or plasma centers to screen for Treponema pallidum antibodies, and the CA 125 II cancer assay for use as "an aid in the detection of residual epithelial ovarian cancer," according to the company. The second-generation CA 125 test "enhances low-end sensitivity." The Captia was cleared via 510(k) while the CA 125 II assay was approved by PMA supplement...
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