Device Recall ABX PENTRA Cholesterol CPref. A11A01634

  • 모델명 / 제조번호(시리얼번호)
    All Lots
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 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
    The ABX PENTRA Cholesterol CP ref. A11A01634 is an in vitro diagnostic assay for quantitative determination of cholesterol in human serum and plasma based on an enzymatic photometric test (Trinders reaction). The assay is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives.
  • Manufacturer
  • 1 Event

제조사

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