Device Recall UltraVision Detection System, AntiPolyvalent, AlkPhos/Fast Red (Ready to Use)

  • 모델명 / 제조번호(시리얼번호)
    Catalog number: TP-015-AF; Lot Number: PAF110420, Exp. 4/2012; Lot Number: PAF110503, Exp 6/2012; Lot number :PAF110722, Exp 9/2012.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) FL, IL, MA, TX and countries of Denmark, Turkey, Italy, Poland, Canada, Japan, Germany, Egypt and Greece.
  • 제품 설명
    UltraVision Detection System; || Anti-Polyvalent, Alk-Phos/Fast Red (Ready to Use) || Manufactured by: Lab Vision Corporation || 46360 Fremont Blvd, Fremont, CA 94538 || Product Usage: These products detect specific antibodies bound to an antigen in tissue sections. The specific antibody is located by a biotin-conjugated secondary antibody. This step is followed by the addition of streptavidin-enzyme conjugate that binds to the biotin preset on the secondary antibody. The specific antibody, secondary antibody, and streptavidin-enzyme complex is then visualized with an appropriate substrate/chromogen.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Lab Vision Corporation, 46360 Fremont Blvd, Fremont CA 94538-6406
  • Source
    USFDA