Device Recall ImmunoCAP Allergen Ri206

  • 모델명 / 제조번호(시리얼번호)
    Article number 14-5274-10, Lot number BDZ0P
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide to include: MN, VA, NC, MO, SC, TX, MA, MI, FL, IL, PA, MD, UT, CO, GA, CA,
  • 제품 설명
    ImmunoCAP Allergen Ri206, Cockroach American, Periplaneta americana || It is an analyte specific reagent and no intended use, however, it is typically used in vitro quantitive assay for the measurement of cockroach allergen IgE in human serum or plasma.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Phadia US Inc, 4169 Commercial Ave, Portage MI 49002-9701
  • 제조사 모회사 (2017)
  • Source
    USFDA