Zdrowie i gospodarka · 22/11/2021

FDA Reclassifies Nucleic Acid-Based Hepatitis C Virus Tests, Renaming from Devices to Tests

The FDA is issuing a final order to reclassify nucleic acid-based HCV RNA tests from class III devices to class II devices, subject to premarket notification, and renaming them under the 'nucleic acid-based hepatitis C virus (HCV) ribonucleic acid tests' classification regulation