As FDA's 2009 H1N1 EUAs Expire, PCR Test Makers Refine Plans for Next Flu Season
July 01, 2010
As FDA's 2009 H1N1 EUAs Expire, PCR Test Makers Refine Plans for Next Flu Season
Around a dozen H1N1 tests have gained EUA approval since the FDA gave its first EUA last April for CDC's PCR-based test. However, only two of these assays have received 510(k) clearance, which allows them to be used beyond the EUA.
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