Device Recall ABX PENTRA Enzymatic Creatinine CPref. A11A01907

  • 모델명 / 제조번호(시리얼번호)
    All Lots
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    U.S. distribution to the following; CA, NY, AL, OK, MN, MS, MD, TX, KY, WV, MT, IL, FL, VA, WA, MI, KS, NE, PA, OH, ID, OR, AR, AZ, NM, NC, SC, GA, TN No foreign distribution.
  • 제품 설명
    ABX PENTRA Enzymatic Creatinine CP ref. A11A01907 reagent is intended for the quantitative in vitro diagnostic determination of creatinine in human serum, plasma and urine based on an enzymatic method of using a multi-step approach ending with a photometric end-point reaction.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Horiba Instruments Inc, 9755 Research Dr, Irvine CA 92618-4626
  • 제조사 모회사 (2017)
  • Source
    USFDA