VARIANT Bthalassemia Short Program Reorder Pack, 500 Tests,

  • Modèle / numéro de série
    Model number: 270-2154; Lot number 70210674, expiry 1/13/13. lot number 70210954, expiry 2/28/13. Both contain Buffer lot numbers AA10685/AA10686, expiry 3/31/13. Model number : 270-0002; Lot number 70010957, expiry 2/28/13. Contains Buffer lot numbers AA10685/AA10686, expiry 3/31/13.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    VARIANT B-thalassemia Short Program Reorder Pack, 500 Tests, For the separation and determination of HbA and HbF and as an aid in the identification of abnormal hemoglobins in whole blood. IVD, Made in United States. || Contents: || 1. Elution Buffer 1, 3 x 1900 mL sodium phosphate buffer || 2. Elution Buffer 2, 2 x 1800 mL sodium phosphate buffer || 3. Wash/Diluent solution, 2 x 1800 mL deionized water || 4. Analytical cartridge, 1 cation exchange cartridge || 5. 1 Calibrator/Diluent set, 1 Lypholized human red blood cells hemolysate with preservative; deionized water with preservative || 6. 1 CD Rom - CD R with program parameters || 7 Sample vials, 100 x 1.5 mL. Sample vials with pierceable cap || 8. Whole Blood Primer, 10 x 1.0 mL (3), Lypholized human red blood cells hemolysate with preservative; || 9. 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

Fabricant

  • Adresse du fabricant
    Bio-Rad Laboratories, Inc., 4000 Alfred Nobel Drive, Hercules CA 94547-1803
  • Société-mère du fabricant (2017)
  • Source
    USFDA