Device Recall BioPlex 2200 EBV IgG Calibrator Set.

  • 모델명 / 제조번호(시리얼번호)
    Lot #46704.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA including the following states: AL, AZ, CA, CT, FL, GA, HI, IL, IN, LA, MA, MD, MI, MN, NC, NJ, NY, OH, OR, PA, TN, TX, VA, WA, and WI; and countries of: Australia, Czech Republic, France, Germany, Italy and Republic of Korea.
  • 제품 설명
    BioPlex 2200 EBV IgG Calibrator Set. Catalog #663-1200. || Product is labeled in part: "BIO-RAD***BioPlex 2200 EBV IgG Calibrator Set***7 x 0.5 mL***A Calibrator set for the BioPlex 2200 EBV IgG Reagent Pack***UNITED STATES, Bio-Rad Laboratories, Inc., Hercules, CA 94547". || BioPlex 2200 EBV IgG Calibrator Set is intended for the calibration of the BioPlex 2200 EBV IgG Reagent Pack.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Bio-Rad Laboratories, 6565 185th Ave NE, Redmond WA 98052-5039
  • 제조사 모회사 (2017)
  • Source
    USFDA