Device Recall Pointe Scientific CRP(HS) Wide Range Control and Wide Range Standard Set

  • Modèle / numéro de série
    Model #'s C7568-CTL and C7568-STD  Lots: C7568-STD: 717303-131. Exp 6/2009. C7568-CTL: 902701-111 and 902701-131. Exp 1/2011.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including CA, MS, NJ, PA, HI, MD, FL, OK, NV. Foreign Distribution to CHILE
  • Description du dispositif
    Pointe Scientific CRP(HS) Wide Range Control Set and || Pointe Scientific CRP(HS) Wide Range Standard Set || 5 Levels of 1 x 2 ml ready to use calibrator or standard The Pointe Scientific CRP (HS) Wide Range Multi-Calibrator Set is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only. The Pointe Scientific CRP (HS) Wide Range Multi-Standard Set Is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Medtest Holdings, Inc., 5449 Research Dr, Canton MI 48188-2261
  • Société-mère du fabricant (2017)
  • Source
    USFDA