510(K) clearance for Cortecs' Helicobacter pylori test:
This article was originally published in Clinica
Cortecs has received clearance from the FDA to market its rapid test for the bacteria Helicobacter pylori in the US to hospitals, clinical laboratories and some doctors' offices. The company has also applied for a waiver under the Clinical Laboratories Improvements Amendment to sell the test to the remaining doctors' offices in the US. Becton Dickinson will distribute both the H pylori test and another test for glandular fever in that country.
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