Device Recall SPINALSCOPICS

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 46130, 46131, 46132, 46140, 46141, 46142, 46150, 46151, 46152, 46160, 46161, 46162, 46170, 46171 and 46172.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including states of AK, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, MO, NC, ND, NH, NM, NY, OR, PA, SC, SD, TN, TX, VA, WA and WY.
  • 제품 설명
    Quantimetrix SpinalScopics Spinal Fluid Cell Count Control. || Spinalscopics is a plastic bottle liquid spinal fluid cell count control. This product is intended for monitoring cell counts in patient cerebrospinal fluid samples performed manually using a hemocytometer.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Quantimetrix Corporation, 2005 Manhattan Beach Blvd, Redondo Beach CA 90278-1205
  • 제조사 모회사 (2017)
  • Source
    USFDA