Device Recall MultiAnalyte Urine DAU Cutoff Calibrator

  • Modèle / numéro de série
    Catalog number 0803; Lot 1101136K3, exp 1/28/13
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: AL, FL, GA, IN, NC, NH, and TX; and country of: Germany.
  • Description du dispositif
    Multi-Analyte Urine DAU Calibrator (15 mL HDPE bottle inside a cardboard box) || For in vitro diagnostic use only. || Lin-Zhi International, Inc.. || 670 Almanor Ave. || Sunnyvale, CA 94085 || intended use: Drug abuse detection.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Lin-Zhi International Inc, 670 Almanor Ave, Sunnyvale CA 94085-3513
  • Société-mère du fabricant (2017)
  • Source
    USFDA