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news.Corgenix Medical has received 510(k) clearance from the FDA for the company's IgG Anti-AtherOx Test Kit, to detect antibodies in individuals with important autoimmune diseases.
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The IgG Anti-AtherOx Test Kit is CE marked for use in the EU. The company will market the new product worldwide through its existing distribution network.
Luis Lopez, chief medical officer of Corgenix, said: “This test will be an important addition to our other phospholipid products currently used worldwide by physicians to identify patients with thrombosis-associated antibodies. It provides vital clinical information for physicians treating individuals with SLE and antiphospholipid syndrome, both of which are very important clinical problems.”