In Brief: Sanofi Diagnostics Pasteur
This article was originally published in The Gray Sheet
Sanofi Diagnostics Pasteur: Launches Access Chlamydia test in U.S. The assay, which received FDA 510(k) clearance in September 1994 ("The Gray Sheet" Oct. 20, 1994, p. 20), uses paramagnetic particles coated with chlamydia-specific monoclonal antibodies. The 30-minute test is designed for use with the company's Access system but is compatible with standard automated immunoassay analyzers...
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