Device Recall PTS Panels Creatinine test strips.

  • 모델명 / 제조번호(시리얼번호)
    Cat No. 1720; and Lot number F103
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- Nationwide Distribution including the states of CA and VA., and the countries of China, Poland, Ireland and France.
  • 제품 설명
    PTS Panels Creatinine test strips. || PTS Panels Creatinine Test Strips are intended to measure creatinine in whole blood. Creatinine measurements are used in the diagnosis and treatment of renal (kidney) diseases and in the monitoring of renal dialysis. This system is intended for the professional use for accurately and reproducibly measuring creatinine in human whole blood obtained from a finger stick sample
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Polymer Technology Systems, Inc., 7736 Zionsville Rd, Indianapolis IN 46268-2175
  • 제조사 모회사 (2017)
  • Source
    USFDA