Device Recall Access Immunoassay Systems Hybritech free PSA Calibrator

  • 모델명 / 제조번호(시리얼번호)
    Part Number: 37215, Lot Number: 715293.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution -- OH, CA, TX, OR, MD, MO, FL and PA.
  • 제품 설명
    Beckman Coulter Access Hybritech free PSA Calibrators, REF 37215. || The Access Hybritech free PSA assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of free prostate specific antigen (PSA) in human serum using the Access Immunoassay System.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Beckman Coulter Inc, 200 S Kraemer Blvd, Brea CA 92822-6208
  • Source
    USFDA