Device Recall Rubella IgG EIA test kit

  • 모델명 / 제조번호(시리얼번호)
    Lot F1108
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: NE, NY, FL, GA, MA, OR, WI, MN, MI, MS, NC, CA, MD, MO, IA, DC
  • 제품 설명
    Rubella IgG EIA test kit, containing 1 Rubella IgG Microplate, 1 Negative Control, 1 High Positive Control, 1 Low Positive Control, 1 Substrate, 1 Stop Reagent. Labeled: Distributed by: Bio-Rad Laboratories-Redmond, WA 98052 || For the qualitative, semi-quantitative and quantitative detection of human IgG antibodies to rubella virus in human serum by enzyme immunoassay, to aid in the assessment to the patient's immunological response to rubella, and as a qualitative screening test to determine the immune status of individuals, including women of childbearing age.
  • Manufacturer
  • 1 Event

제조사

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