Meridian Bioscience
Beckman Coulter, Siemens Healthineers, Abbott, Others Gain 510(k) Clearances in March
The US Food and Drug Administration granted clearances for testing instruments, a blood clot drug companion diagnostic test, and infectious disease tests, among other devices.
Former Magellan Diagnostics Execs Plead Guilty in Faulty Lead Testing Case
The executives pleaded guilty to concealing a device malfunction that produced inaccurately low lead test results.
Former Magellan Diagnostics CEO Pleads Guilty in Lead Testing Defect Case
The CEO agreed to plead guilty to a single count of violating the Food, Drug and Cosmetic Act.
OndaVia will get $250,000 for its second-place test while GlucoSentient and the University of Texas-Austin will get $100,000 for third place.
Meridian Bioscience Gets FDA OK for H. Pylori Immunoassay
Premier HpSA Flex is an enzyme immunoassay used to qualitatively detect H. pylori-specific antigens in fresh, frozen, or preserved human fecal specimens.