Device Recall Pointe Scientific Hitachi AST Reagent

  • 모델명 / 제조번호(시리얼번호)
    Catalog numbers: HA461, HA761 , HA961 and lot codes:022204, 034801, 102401, 119503, and 134101.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Pointe Scientific Hitachi AST Reagent || R1 : PE plastic bottle w/PP plastic cap. || R2: PE plastic bottle w /PP plastic cap. || Product Usage: || Two Part Chemistry Reagent For the quantitative determination of Aspartate Aminotransferase (ASl) in human serum on Hitachi analyzers.
  • Manufacturer
  • 1 Event

제조사

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