Device Recall Vina Green(tm) Chromogen Kit

  • 모델명 / 제조번호(시리얼번호)
    Catalog number VG807H, lot 060211 and 101211; expiration 5/2013; Catalog number VG807S, lot 053111, 060211; both with expiration of 5/2013; lot 101211, Expiration 8/2013.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, including the states of WI, KY, CA, GA, IN, MA, IL, MD, NC, LA. AZ, TX, NC, NJ, MO, NY, PA, OH, DC, MI, WA, and CO, and the countries of Canada, Sweden, Germany, Italy, and Switzerland.
  • 제품 설명
    BioCare Medical Vina Green Chromogen Kit; 25 mL, 100ml IVD. Kits include: Vina Green Chromogen 1. 0 mL; Vina Green Buffer, 25 mL and Vina Green Dropper Bottle. BioCare Medical, Concord, CA 94520. || Vina Green is intended for both IHC and ISH applications including HPV, CMV, EBV, Kappa, TTF-1, Ki-67 and other targets/antigens such as blood and lymphatic vessels and basal and myoepithelial cells.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Biocare Medical Llc, 4040 Pike Ln, Concord CA 94520
  • 제조사 모회사 (2017)
  • Source
    USFDA