Device Recall Orasure QuickFlu Rapid AB Test

  • Modelo / Serial
    510 k K083746  Catalog Number 1001-0320 - 22 test kits Catalog 1001-0322 - 12 test kits
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution-including the states of NJ, NY, and PA.
  • Descripción del producto
    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.
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    Princeton Biomeditech Corp, 4242 US Highway 1, Monmouth Junction NJ 08852-1905
  • Empresa matriz del fabricante (2017)
  • Source