Device Recall Mach 4 Universal HRP Polymer Kit

  • Modèle / numéro de série
    Lot number 082715;  Expiry 01/2017.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution in the states of: KS, CA, AZ, OR, FL, KS, CO, MA, KY, NY, IL, OR, MO, NC, TX, PA, OK. SC, TN, PA, TN, GA, and OR. Hungary, Canada, Boliva
  • Description du dispositif
    Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; || Catalog number M4U534L; || For In Vitro Use || Immunology: MACH 4 Universal HRP-Polymer is a horseradish peroxidase (HRP)-antibody conjugate system intended for use in the detection of mouse lgG and lgM, and rabbit IgG primary antibodies on formalin-fixed, paraffin-embedded (FFPE) tissues in an immunohistochemistry (IHC) procedure. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Biocare Medical, LLC, 4040 Pike Ln, Concord CA 94520-1227
  • Société-mère du fabricant (2017)
  • Source
    USFDA