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In Brief: American Biogenetic Sciences

This article was originally published in The Gray Sheet

Executive Summary

American Biogenetic Sciences: Plans fourth quarter launch of its FiF functional intact fibrinogen test following 510(k) clearance by FDA. FiF is intended to provide a "rapid and direct quantitative measurement of clotable levels of fibrin protein in plasma," ABS says. The clearance covers use of the product "for the testing of conditions in which blood coagulation is involved" such as "disseminated intravascular coagulation, cardiovascular disease and primary fibrinolysis." The FiF test is ABS' second commercial test; the company launched its TpP thrombus precursor protein test earlier this year following FDA clearance in late 1996 ("The Gray Sheet" Nov. 4, 1996, I&W-6)...

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