D10 Hemoglobin A1c Program Reorder Pack: 400 tests

  • Model / Serial
    Model number: 220-0101; Lot number/Expiry: 20010946. 11/30/12; 20011075, 11/30/12;  Contain Buffer lot AA10888/AA10889, expiry 3/31/13;  20011077, 11/30/12; 20011079, 11/30/12; 20011081, 11/30/12. Contain Buffer lot AA10440/AA10441, expiry 2/28/13.
  • 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
    D-10 Hemoglobin A1c Program Reorder Pack; 400 tests; || For the determination of Hemoglobin A1c in human whole blood. IVD || Contents: || 1. Elution Buffer 1 2 x 2000 ml Bio-Tris Phosphate Buffer || 2. Elution Buffer 2 1 x 1000 ml Bio-Tris Phosphate Buffer || 3. Wash/Diluent 1 x 1600 mL Deionized water || 4. Analytical cartridge - 1 cation exchange cartridge || 5. Floppy Diskette 1-program parameters || 6. Calibrator/Diluent set. 2 levels of calibrator, 3 vial each: lyophylized human blood cell hemolysate with preservative; 1 bottle 100 mL or diluent deionized water. || 7. Whole Blood Primer: 4 vials Lyophylized human red blood cells hemolysate with preservative. || 8. Sample vials, 100 x 1.5 mL Polypropylene with pierceable lid || 9 Thermal paper - 1 roll || 10. Instruction manual || Made in United States || 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