Devices

Device Recall Enzymatic assay for the determination of Acetaminophen

  • 모델명 / 제조번호(시리얼번호)
    Lot codes: 11021500 7/31/2016 12361201 5/31/2017 11031700 9/30/2018 15247301 8/31/2017 11071400 1/31/2016 18036001 11/30/2017 11071600 8/10/2016 19329601 1/31/2018 11101500 1/21/2016 20511301 5/31/2018 11111600 4/30/2018 24076801 8/31/2018 60482201 2/29/2016 60852601 5/31/2016 61385701 9/30/2016 62032101 1/31/2017
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Roche Acetaminophen assay || 03255379160-HAcetaminophen (P) || 20767174160- cobas c Integra AAcetaminophen150 test
  • Manufacturer
    Roche Diagnostics Corporation
  • 1 Event

제조사

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