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Zdrowie i gospodarka · 23/09/2024

FDA Reclassifies CMV DNA Quantitative Assay Devices for Transplant Patient Management

The FDA is issuing a final order to reclassify CMV DNA quantitative assay devices intended for transplant patient management, moving them from a post-amendments class III device to a class II device, subject to premarket notification.

Source: Federal Register — Food and Drug AdministrationOpen original release →