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NEW YORK – The US Food and Drug Administration on Wednesday proposed the reclassification of two types of hepatitis C virus (HCV) diagnostic tests from class III to class II, meaning the devices will go through the agency's 510(k) pathway for clearance instead of the more rigorous premarket approval (PMA) pathway if the proposal is finalized.

The two types of tests are nucleic acid-based HCV ribonucleic acid (RNA) devices intended for the detection or genotyping of HCV RNA and certain HCV antibody devices intended for the detection of antibodies to HCV.

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