Device Recall AtheNA MultiLyte MMV Test System AtheNA MultiLyte MMRV Test System A93111G

  • Modelo / Serial
    11120087 11120165  11110125 : (This is an amendment to add the additional lot 11110125 which was left off.. This amendment was made on 6/6/2012.)
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution.
  • Descripción del producto
    AtheNA Multi-Lyte MMV Test System- A93111G || A microparticle-based immunoassay intended for the qualitative presumptive detection of IgG class antibody to the Mumps virus in human serum using the AtheNA Multi-Lyte Test System. The test system is intended to be used for determination of a previous infection with the Mumps virus.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Zeus Scientific, Inc., 200 Evans Way, Branchburg NJ 08876-3767
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA