Device Recall BioPlex 2200 Syphilis IgG Control Set

  • 모델명 / 제조번호(시리얼번호)
    Catalog #: 663-1430 Lot #: 46636
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA and countries including: Canada, Czech Republic, France, Germany, and Italy.
  • 제품 설명
    BIO-RAD BioPlex 2200 Syphilis IgG Control Set. Lot # 46636 || The BioPlex 2200 Syphilis IgG Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 Syphilis IgG Reagent Pack in the clinical laboratory.
  • Manufacturer
  • 1 Event

제조사

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