Device Recall QUANTIMETRIX URINE DIPSTICK CONTROL

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 47160, 47170, 47180, 47190, 47200 and 47210.
  • 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 Dip and Spin Control Urine Dipstick/Microscopics Control. || The intended use is to validate the performance of the Multistix, Chemstrip, Uriscan, QuickVue, Diascreen and other urinalysis reagent strips, and as a control for confirmatory tests such as Acetest, Clinitest, and Icotest reagent tablets, and as a control for hCG methods. In addition, the Dip and Spin Control is intended as a means of validating the processing and centrifugation of patient urine samples prior to the microscopic evaluation of urine sediment.
  • Manufacturer
  • 1 Event

제조사

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