Device Recall MESOMARK

  • 모델명 / 제조번호(시리얼번호)
    Lot: 57K04510, Item # 801-905, Expiration Date: December 14, 2010 and Lot: 57K04409, Item# 801-905, Expiration Date: June 15, 2010
  • 의료기기 분류등급
  • 의료기기 등급
    HDE
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including UT
  • 제품 설명
    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
  • 1 Event

제조사

  • 제조사 주소
    Fujirebio Diagnostics, Inc., 201 Great Valley Pkwy, Malvern PA 19355-1308
  • 제조사 모회사 (2017)
  • Source
    USFDA