Devices

MESOMARK

  • Model / Serial
    Model Catalog: 801-900 (Lot serial: 57K04510); Model Catalog: 801-900 (Lot serial: 57K04409 (ALREADY EXPIRED))
  • Product Description
    MESOMARK KITS
  • Manufacturer
    FUJIREBIO DIAGNOSTICS INC.
  • 1 Event

Manufacturer

FUJIREBIO DIAGNOSTICS INC.

3 devices with a similar name

Learn more about the data here

MESOMARK reagent
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Cis-Bio Company
Mesomark Kits
Device Recall MESOMARK
  • Model / Serial
    Lot: 57K04510, Item # 801-905, Expiration Date: December 14, 2010 and Lot: 57K04409, Item# 801-905, Expiration Date: June 15, 2010
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    HDE
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including UT
  • Product Description
    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.