Dune Medical Devices has obtained an approvable letter related to its premarket approval application (PMA) for the breast cancer detection system from the US Food and Drug Administration (FDA). The letter indicates that the system's PMA ...
The US Food and Drug Administration (FDA) has granted premarket approval (PMA) to Roche's new fully automated COBAS AmpliPrep / COBAS TaqMan CMV test to quantify cytomegalovirus' (CMV) DNA in human plasma specimens. The real-time ...
Tags: Roche, FDA, Viral Load Test, PCR-based CMV test
The US Food and Drug Administration (FDA) has granted premarket approval (PMA) to Beckman Coulter's simple, non-invasive Prostate Health Index (phi) blood test. The phi test, indicated for use in men with a prostate-specific antigen (PSA) ...
Tags: phi blood test, Prostate Health Index Test, immunoassay systems