Device Recall BD GeneOhm MRSA Assay

  • Modelo / Serial
    Catalog Number: 441242, Lot Numbers: 03T08206, 03T08207, 03T08207a and 03T08221a; and  Catalog Number: 441244, Lot Number: 03T08218.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US (CA, IL, IN, KT, MD, ME, MN, MO, MT, NC, NJ, NY, OK, PA, TN, TX, UT, VA, and WI), Belgium and Japan.
  • Descripción del producto
    BD Diagnostics, BD GeneOhm MRSA Assay, REF: 441242 (200 Reaction Kit) and 441244 (48 Reaction Kit). || For the rapid detection of methicillin resistant MRSA DNA in nasal specimen.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    BD Diagnostics (GeneOhm Sciences, Inc), 6146 Nancy Ridge Dr, San Diego CA 92121
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA