Devices

Device Recall Lactate Dehydrogenase IFCC

  • 모델명 / 제조번호(시리얼번호)
    Catalog Numbers: 11822837190; 05401666190; 03183700190; 05171881190; 03183700190.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US (nationwide) including PR.
  • 제품 설명
    Lactate. || Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems for the quantitative determination of lactate concentration in plasm and cerebrospinal fluid.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
  • 1 Event

제조사

Roche Diagnostics Operations, Inc.
  • 제조사 주소
    Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • 제조사 모회사 (2017)
    Roche Holding AG
  • Source
    USFDA