D10 Hemoglobin A1c Program Reorder Pack: 400 tests

  • 모델명 / 제조번호(시리얼번호)
    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.
  • 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
    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

제조사

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