Devices

Device Recall Perkin Elmer NEONATAL TOTAL GALACTOSE KIT

  • Modèle / numéro de série
    Lot Numbers: 618201, 619200, 618263
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution.
  • Description du dispositif
    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
    Perkinelmer
  • 1 Event

Fabricant

Perkinelmer
  • Adresse du fabricant
    Perkinelmer, 940 Winter Street, Waltham MA 02451
  • Société-mère du fabricant (2017)
    Perkin Elmer Inc.
  • Source
    USFDA