Synchron Phenobarbital (PHE) Drug Calibrator 1

  • 모델명 / 제조번호(시리얼번호)
    M810440 and earlier
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution--USA (nationwide) and the country of Canada.
  • 제품 설명
    Synchron Phenobarbital (PHE) Drug Calibrator 1, P/N 469600, || Classification Product Code: KLT. || Subsequent Product Codes: DIP, KLS, LCD, LCQ, LCR, LFN. || The Beckman Coulter SYNCHRON Systems DRUG CALIBRATOR 1, when used in conjunction with SYNCHRON reagents, is intended for use on the SYNCHRON Systems for the calibration of Carbamazepine, Phenobarbital, Phenytoin, Theophylline, and Valproic Acid.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • 제조사 모회사 (2017)
  • Source
    USFDA