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In Brief: Cortecs

This article was originally published in The Gray Sheet

Executive Summary

Cortecs: Receives 510(k) clearance from FDA for its Helisal point-of-care Helicobacter pylori rapid blood diagnostic kit. The kit uses a whole blood sample from a finger-stick to determine results within five minutes "without the use of any additional equipment," Cortecs says. Boehringer Mannheim will market the test in the U.S. under the name AccuStat H. pylori via an exclusive distribution agreement announced last year ("The Gray Sheet" Nov. 20, 1995, In Brief). In February, Quidel's Quick Vue rapid H. pylori whole blood finger-stick test became the first point-of-care H. pylori test to gain FDA clearance ("The Gray Sheet" March 4, In Brief)...
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