VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 1600 tests,

  • Model / Serial
    Model number: 270-2417; Lot number 70211073, expiry 12/31/2011. Contains Buffer lot: AA10758/AA10759, expiry 12/31/11.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 1600 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, 4 cation exchange Guard cartridges. || 4. CD-ROM 1 - CD Rom with program parameters || 5. Calibration/Diluent set - 2 levels, 2 vial 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

Manufacturer

  • Manufacturer Address
    Bio-Rad Laboratories, Inc., 4000 Alfred Nobel Drive, Hercules CA 94547-1803
  • Manufacturer Parent Company (2017)
  • Source
    USFDA