Device Recall A1CNOW

  • 모델명 / 제조번호(시리얼번호)
    Model Number 03022-Lot Numbers 0707812, 0707813, 0707814, and 0707815.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide including states of AK, AL, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, MA, MD, MI, MN, MS, NC, NJ, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI and Puerto Rico.
  • 제품 설명
    A1CNOW+ with sampler 10-Test Kits (Product No: 3022), Metrika, Inc., Sunnyvale, CA 94085. (This test provides quantitative measurement of the percent of glycated hemoglobin (%A1C) levels in capillary (fingerstick) or venous whole blood samples. The test is used by professional healthcare providers to monitor long-term glycemic control in people with diabetes. The product is sold as a kit with a disposable monitor and reagents for ten A1C tests and is suitable for use at the point-of-care.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Metrika Inc, 510 Oakmead Pkwy, Sunnyvale CA 94085-4022
  • Source
    USFDA