Device Recall Mach 4 Universal HRP Polymer Kit

  • Modelo / Serial
    Lot number 082715;  Expiry 01/2017.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    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
  • Descripción del producto
    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

Fabricante

  • Dirección del fabricante
    Biocare Medical, LLC, 4040 Pike Ln, Concord CA 94520-1227
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA