Device Recall Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator

  • 모델명 / 제조번호(시리얼번호)
    Product catalog number: A68827; Lots 1308006, 1308131, Expiry: March 28, 2015.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution including CA.
  • 제품 설명
    Single Analyte DAU Calibrator (5 mL) || Norbuprenorphine: Cutoff Calibrator; || IVD - for in vitro diagnostic use only; || Lin-Zhi International || Sunnyvale, CA || The Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator is used for qualitative and semi-qualitative calibration of the Lin-Zhi Internal, Inc. Buprenorphine (BUP) enzyme Immunoassay (REF # A53684) on the Synchron Clinical Analyzer
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Lin-Zhi International Inc, 670 Almanor Ave, Sunnyvale CA 94085-3513
  • 제조사 모회사 (2017)
  • Source
    USFDA