Devices

Device Recall MESOMARK

  • Modelo / Serial
    Lot: 57K04510, Item # 801-905, Expiration Date: December 14, 2010 and Lot: 57K04409, Item# 801-905, Expiration Date: June 15, 2010
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    HDE
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including UT
  • Descripción del producto
    MESOMARK Humanitarian Device. Authorized by Federal Law for use as an aid in monitoring of patients diagnosed with mesothelioma. Each kit contains 96 tests. || MESOMARK is an enzyme linked immunosorbent assay (ELISA) for the quantitative measurement of Soluble mesothelin Related Peptides (SMRP) in human serum. Measurement of SMRP may aid in the monitoring of patients diagnosed with epithelioid or biphasic mesothelioma. MESOMARK values must be interpreted in conjunction with all other available clinical and laboratory data.
  • Manufacturer
    Fujirebio Diagnostics, Inc.
  • 1 Event

Fabricante

Fujirebio Diagnostics, Inc.
  • Dirección del fabricante
    Fujirebio Diagnostics, Inc., 201 Great Valley Pkwy, Malvern PA 19355-1308
  • Empresa matriz del fabricante (2017)
    Miraca Holdings, Inc.
  • Source
    USFDA