Device Recall DSL108000 Active IPTH ELISA

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 891198, 990980, 991448
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including the states of CA, CT, IA, IL, MI, NY, SC, and TX
  • 제품 설명
    Active I-PTH Enzyme-Linked Immunosorbent Assay(ELISA), Part Number: DSL-10-8000 || The DSL-10-8000 ACTIVE I-PTH Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of I-PTH in serum or plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis of hyperparathyroidism
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • 제조사 모회사 (2017)
  • Source
    USFDA