510(k) for four Corgenix Medical's diagnostic test kits:
This article was originally published in Clinica
The FDA has cleared four of Corgenix Medical's diagnostic products for testing a patient's risk of thrombosis. Three of the assays detect the presence of antibodies to beta 2 glycoprotein I which indicate the increased risk of clinical thrombosis developing in patients with deep venous thrombosis, heart attacks and strokes. The fourth assay uses a monoclonal antibody specific to the free protein S and measures the levels of protein S which regulates blood coagulation.
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