Device Recall Pointe Scientific, Med Test, Pointe Scientific autoHDL Reagent

  • Modèle / numéro de série
    Catalog numbers: H7545-R1, 12-H7545-162, H7545-1000, HDL600 Lot number: 430402
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including MI, FL, CA, TX, CT, PR and Internationally to Canada.
  • Description du dispositif
    Pointe Scientific autoHDL Reagent H7545 || H7545-R1 in a bulk cube container or HDPE plastic bottle || H7545-1000 kit includes 1x750 ml of R1 and 1x250 ml of R2 || 12-H7545-162 kit includes 3x40 ml of R1 and 3x14 ml of R2 || HDL600 kit includes 3x40 ml of R1 and 3x14 ml of R2 || Kits: HDPE plastic bottle, PP plastic caps. || Bulk: PE plastic cube containers, PP plastic caps. || Quantitative determination of high density lipoprotein cholesterol in human serum or plasma. In vitro diagnostic use only.
  • Manufacturer
  • 1 Event

Fabricant

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