Devices

Device Recall Access Ostase Calibrators

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: Expiration dates: 013489 11/30/2010  111530 09/30/2011 013490 01/31/2011  113463 10/31/2011 015210 02/28/2011  114259 10/31/2011 018854 03/31/2011  114260 11/30/2011 020419 05/31/2011  115484 12/31/2011 022834 06/30/2011  116658 01/31/2012 109632 07/31/2011
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) and the countries of Algeria, Argentina, Australia, Austria, Belgium, Canada, China, Colombia, Czech Republic, Denmark, France, Georgia, Germany, Greece, Hong Kong, Hungary, India,Ireland, Italy, Japan, Jordan, Lebanon, Liechtenstein, Mexico, Morocco, Netherlands, New Zealand, Panama, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Venezuela.
  • 제품 설명
    Access Ostase Calibrators, Part Number: 37305, || Subsequent Product Code: JIS. || The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access Immunoassay Systems.
  • Manufacturer
    Beckman Coulter Inc.
  • 1 Event

제조사

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

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Device Recall Access Ostase Calibrators
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers:  013490, 015210, 018854, 020419, 022834, 109632
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide in US and worldwide to: Algeria, Argentina, Australia, Austria, Belgium, Canada, China, Colombia, Czech Republic, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Jordan, Lebanon, Liechtenstein, Mexico, Morocco, New Zealand, Panama, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom
  • 제품 설명
    Access Immunoassay Systems || Ostase Calibrators, Part Number: 37305 || The Access Ostase Calibrators are used to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access Immunoassay Systems.
  • Manufacturer
    Beckman Coulter Inc.