Devices

Device Recall Lipase

  • Modèle / numéro de série
    Lot numbers: 428000, 404175, and 404245
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution in the states of West Virginia and Puerto Rico
  • Description du dispositif
    Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284 || Product Usage: || For Professional Use for the quantitative in vitro determination of Lipase in human serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.
  • Manufacturer
    Randox Laboratories Ltd.
  • 1 Event

Fabricant

Randox Laboratories Ltd.
  • Adresse du fabricant
    Randox Laboratories Ltd., 55 Diamond Road, Crumlin (North) Ireland
  • Société-mère du fabricant (2017)
    Randox Holdings Limited
  • Source
    USFDA

Un dispositif médical avec un nom similaire

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Device Recall Lipase
  • Modèle / numéro de série
    List Numbers: 7D80-20 and 7D80-30; Control Numbers: 37033HW00, 33032HW00, 30053HW00, 47048HW00, 45067HW00, 43002HW00, 42016HW00 & 42010HW00
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide, including USA, Australia, Brazil, Canada, Chile, El Salvador, Dominican Republic, Ecuador, Germany, Hong Kong, Japan, Mexico, New Zealand, Panama, Puerto Rico, Singapore, South Korea, Thailand, and Venezuela.
  • Description du dispositif
    Clinical Chemistry Lipase, List Numbers: 7D80-20 and 7D80-30
  • Manufacturer
    Abbott Laboratories Inc.