Device Recall Perkin Elmer NEONATAL TOTAL GALACTOSE KIT

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 618201, 619200, 618263
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    NEONATAL TOTAL GALACTOSE KIT || Product Numbers: 3029-0010, 3029-001B. || This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Perkinelmer, 940 Winter Street, Waltham MA 02451
  • 제조사 모회사 (2017)
  • Source
    USFDA