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FDA Watch: First Zika Assay Gets Green Light for Marketing
From - Laboratory Industry Report
Over the past several years, the FDA has issued Emergency Use Authorization (EUA) for over a dozen different tests for…
From - Laboratory Industry Report
Over the past several years, the FDA has issued Emergency Use Authorization (EUA) for over a dozen different tests for…
From - Laboratory Industry Report
The FDA broke new ground by clearing a pair of STD screening assays for detecting chlamydia and gonorrhea for use with extragenital specimens, specifically from the…
From - Laboratory Industry Report
After a couple of years of dormancy, the FDA laboratory developed test (LDT) enforcement volcano stirred on…
From - Lab Compliance Advisor
April 22, 2019 was supposed to the last day to comment on newly proposed FDA guidance on changing the Section 510(k) premarket review process for…
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