FDAFDA · Alimentos y medicamentos·N.º oficial Z-2306-2012
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.
Publicado el 12 de septiembre de 2012 · Inicio del retiro: 9 de marzo de 2012
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Princeton Biomeditech Corp
- Distribuidor
- Nationwide Distribution-including the states of NJ, NY, and PA.
- Lote
- 510 k K083746 Catalog Number 1001-0320 - 22 test kits Catalog 1001-0322 - 12 test kits
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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