Device Recall IRISpec" CA/CB twopart urine chemistry control twin set

  • Modèle / numéro de série
    Iris Diagnostics part number 800-0074, lot number 131-12.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. || Intended Use: IRISpec CA/CB is an assayed QC material for monitoring of the urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Iris Diagnostics, 9172 Eton Ave, Chatsworth CA 91311-5805
  • Source
    USFDA