Device Recall BioRad Variant II Turbo Link Hemoglobin Testing System

  • 모델명 / 제조번호(시리얼번호)
    Catalog No. 270-2716 Lot No. 70291030, expiration date 2/28/2010 Lot No. 70392119, expiration date 3/31/2010 Lot No. 70292119R, expiration date 3/31/2010
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA including states of: OH, MN, SC and VA; and country including: Japan.
  • 제품 설명
    Bio-Rad Variant II Turbo Link Hemoglobin Testing System, including Hemoglobin A, Program Reorder Pack 1600 Tests, Program Buffer A, Buffer B, Cartridge Set, Analytical Cartridge, Guard Cartridge, Calibrator, Accessory Box, Instruction Manual and Quick Guide || Intended use: Measurement of Hemoglobin A1c in human whole blood.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Bio-Rad Laboratories Inc, 4000 Alfred Nobel Dr, Hercules CA 94547-1803
  • Source
    USFDA