Devices

Device Recall BD GeneOhm MRSA Assay

  • Modèle / numéro de série
    Catalog Number: 441242, Lot Numbers: 03T08206, 03T08207, 03T08207a and 03T08221a; and  Catalog Number: 441244, Lot Number: 03T08218.
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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
    BD Diagnostics (GeneOhm Sciences, Inc)
  • 1 Event

Fabricant

BD Diagnostics (GeneOhm Sciences, Inc)
  • Adresse du fabricant
    BD Diagnostics (GeneOhm Sciences, Inc), 6146 Nancy Ridge Dr, San Diego CA 92121
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA