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The FDA has reclassified antigen-based rapid influenza virus antigen detection test systems (RIDTs) from Class I to Class II devices and has introduced special controls aimed at improving the quality of testing. Read More
Zimmer Biomet’s Warsaw, Ind., medical device facility was hit with a massive, 58-page Form 483 arising from an inspection carried out from September to November of 2016. Read More
Massachusetts–based, Hologic has received PMA approval from the FDA for its hepatitis C virus assay for measuring viral load and confirming infection. Read More