Device Recall Spectrolyse PAI1

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 120425 and 120601
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: USA including states of: FL, IN, IL, and WA.
  • 제품 설명
    Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human plasma. || Catalog Number: 101201 || For the determination of Plasminogen Activator Inhibitor Type 1 (PAI-1) activity in human plasma. The test is for in Citro diagnostic use.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Sekisui Diagnostics Llc, 500 West Avenue, Stamford CT 06902
  • 제조사 모회사 (2017)
  • Source
    USFDA