Device Recall EVOLIS Assay Protocol Files ( APF) Software

  • 모델명 / 제조번호(시리얼번호)
    APF Version 4.4 Software Version 2.00 2009/05 LOT=V4.4-0505-2
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution -- Including Puerto Rico.
  • 제품 설명
    Software CD is labeled in part: || "BLOOD VIRUS DIVISION***BIO-RAD EVOLIS System APF Version 4.4 Software Version 2.00 2009/05***" || The EVOLIS Assay Protocol Files (APF) Software contains assay-specific instructions necessary for the EVOLIS Microplate processing system to process enzyme immunoassays on the EVOLIS instrument, perform data reduction and generate reports.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Bio-Rad Laboratories, 6565 185th Ave NE, Redmond WA 98052-5039
  • 제조사 모회사 (2017)
  • Source
    USFDA