Device Recall Pointe Scientific Creatinine Reagent R2

  • 모델명 / 제조번호(시리얼번호)
    All lots numbers containing the numbers 923202; exp. 2011-08.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, Bolivia, Greece, Guyana, India, Indonesia, Israel, Kenya, Korea, Malaysia, Mexico, Pakistan, Philippines, Russia, Serbia, Sri Lanka, Tanzania, Trinidad and Ukraine.
  • 제품 설명
    Pointe Scientific Creatinine Reagent R2, Pointe Scientific, Inc., Canton, MI; Catalog 3-C7539-L, 7-C7539-R2-30, 7-C7539-R2-125, 7-C7539-R2-250, 8-C7539-R2-30, 8-C7539-R2-125 and 8-7539-R2-250. || For the quantitative determination of creatinine in serum. For in-vitro diagnostic use only.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Pointe Scientific, Inc., 5449 Research Dr, Canton MI 48188
  • 제조사 모회사 (2017)
  • Source
    USFDA