Devices

Device Recall Liquid Alkaline Phosphatase Reagent Set

  • 모델명 / 제조번호(시리얼번호)
    Lots 500701(exp. 7/06), 508001 (exp. 9/06), 513003 (exp. 11/06), 521601 (exp. 2/07), 530101 (exp. 4/07), 534901 (exp. 6/07), 603301 (exp. 8/07) and 607601 (exp. 9/07).
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide, including USA, Bolivia, Cameroon, China, Cyprus, Egypt, Greece, India, Israel, Kenya, Korea, Lebanon, Malaysia, Mexico, Nepal, Nicaragua, Nigeria, Pakistan, Panama, Peru, Philippines, Poland, Russia, Singapore, Thailand, Trinidad, Turkey, Ukraine United Arab Emirates and Venezuela.
  • 제품 설명
    Liquid Alkaline Phosphatase Reagent Set for the quantitative determination of alkaline phosphatase in serum, Manufactured by Pointe Scientific, Inc.; Catalog nos. A7516-150, A7516-450, A7516-625, HA716-246, HA716-2400, HA916-302 and HA916-492. In vitro diagnostic.
  • Manufacturer
    Pointe Scientific, Inc.
  • 1 Event

제조사

Pointe Scientific, Inc.
  • 제조사 주소
    Pointe Scientific, Inc., 5449 Research Dr, Canton MI 48188-2261
  • 제조사 모회사 (2017)
    Medtest Holdings Inc
  • Source
    USFDA

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Device Recall Liquid Alkaline Phosphatase Reagent Set
  • 모델명 / 제조번호(시리얼번호)
    All Lots beginning with 727801; exp. 4/09.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide-USA, Canada, Chile, Cyprus, Ecuador, Greece, India, Italy, Jamaica, Korea, Nigeria, Pakistan, Philippines, Poland, Turkey and The West Indies.
  • 제품 설명
    Liquid Alkaline Phosphatase Reagent Set; Catalog No. A7516-150-SAM, In vitro diagnostic; for the quantitative determination of alkaline phosphatase in serum, Sold by Pointe Scientific, Inc
  • Manufacturer
    Pointe Scientific, Inc.