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FDA

Lyme immunoblot test cleared by FDA

September 6, 2024

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ID-Fish Technology’s iDart Lyme IgG Immunoblot Kit, a stand-alone test for the detection of IgG antibodies against Borrelia-causing Lyme disease, has received FDA clearance. The test contains 31 Lyme antigen bands and is the only Lyme immunoblot test that includes the B. burgdorferi proteins Osp A and Osp B.

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