VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 2000 tests,

  • 모델명 / 제조번호(시리얼번호)
    Model number: 270-2415; Lot number 70211066, expiry 03/31/2012; Lot number 70211068, expiry 3/31/2012. Contains Buffer lot number: AA10758/AA10759, expiry 3/31/12.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide and to New Zealand, Canada, France, England, China, India, Mexico, Italy, Brazil, Australia, Singapore, Thailand, SriLanka, hong Kong, Sweden, Germany, Peru, Jamaica, Uruguay, Columbia, Argentina, Chile, Paraguay and Korea.
  • 제품 설명
    VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 2000 tests, || IVD, Made in United States. || Kit contains: || 1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer || 2. Elution Buffer B 1 x 1500 mL Bis-Tris Phosphate Buffer || 3. Cartridge Set, 2 cation exchange analytical cartridges, 5 cation exchange Guard cartridges. || 4. CD-ROM 1 - CD Rom with program parameters || 5. Calibration/Diluent set - 2 levels, 3 vials each of lyophilized human red blood cell hemolysate with preservative, 1 bottle diluent, 100 mL deionized water. || 6. Whole Blood Primer, 6 x 1 mL, lyophilized human red blood cell hemolysate with preservative, || 7. Sample vials - 2 x 100, 1.5 mL polypropylene vials with pierceable caps. || 8. Instruction Manual. || Bio-Rad Laboratories, Hercules, CA 94547. || Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Bio-Rad Laboratories, Inc., 4000 Alfred Nobel Drive, Hercules CA 94547-1803
  • 제조사 모회사 (2017)
  • Source
    USFDA