2 results
·
17ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
Lazervida 10W diode laser cutter and engraver with Lazervida shield.
FDA Enforcement
Class II
·Ongoing·Flux Technology Inc.·June 11, 2025
Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc Bethlehem, PA 18015 USA. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.
FDA Enforcement
Class II
·Terminated·Princeton Biomeditech Corp·September 12, 2012