Device Recall Pointe Scientific Hitachi AST Reagent

  • Modèle / numéro de série
    Catalog numbers: HA461, HA761 , HA961 and lot codes:022204, 034801, 102401, 119503, and 134101.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    Pointe Scientific Hitachi AST Reagent || R1 : PE plastic bottle w/PP plastic cap. || R2: PE plastic bottle w /PP plastic cap. || Product Usage: || Two Part Chemistry Reagent For the quantitative determination of Aspartate Aminotransferase (ASl) in human serum on Hitachi analyzers.
  • Manufacturer
  • 1 Event

Fabricant

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