Lyme assay receives FDA clearance
by Press Release from Outbreak News Today on (#3S90N)
Gold Standard Diagnostics, Corp. announced the U.S. Food and Drug Administration issued a 510(k) clearance for its Borrelia burgdorferi IgG/IgM ELISA assay. The test is intended as an initial screening assay in the CDC recommended two-steps testing for evidence of antibodies against the Lyme disease bacteria. Both steps can be performed using the same blood sample. GSD's ["]
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