US Food and Drug Administration (FDA) approves Centocor (US) assays:
This article was originally published in Clinica
The US FDA has approved two Centocor (US) diagnostic products. Centocor's CA 125 II ovarian cancer test received PMA supplement approval as an aid to the detection of residual disease, while the Captia Syphilis-G test, for the detection of Treponema pallidum antibodies in serum or plasma, gained 510(k) clearance. Centocor acquired the syphilis test through its 1993 purchase of Mercia Diagnostics (UK) (see Clinica No 488, p1).
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