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Home » HHS Responds to Lyme Disease Uptick With Call for Better, Earlier Tests
HHS Responds to Lyme Disease Uptick With Call for Better, Earlier Tests
September 28, 2012
Companies developing in vitro diagnostic (IVD) tests for Lyme disease should include randomized sampling from at least three geographically distinct U.S. locations in their 510(k) submission to the FDA, an agency official says.