In Brief: Biomira
This article was originally published in The Gray Sheet
Executive Summary
Biomira: Receives 510(k) clearance from FDA to market its Visuwell treponemal syphilis antibody blood test. "For a definitive clinical diagnosis, two types of blood test are used: a non-treponemal screening assay, followed by the confirmatory treponemal antibody test," the firm explains. The new test will be marketed with the firm's Visuwell Reagin, non-treponemal blood test in a microwell format, enabling automation of total syphilis testing, the firm states...
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