Luminex Corporation

One device in the database

  • Model / Serial
    Kit Lot #: IK030B-0001 (US distribution) and Kit Lot # IK030B-1001 (European distribution)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA ( nationwide) and the countries of Belgium, UK and Canada.
  • Product Description
    xTAG CYP2D6 Kit v3 IVD For use with Luminex 100/200 Instrument Luminex Molecular Diagnostics, Inc. 439 University Ave. Toronto, Ontario Canada Catalog # I030B0373 || The xTAG CYP2D6 Kit v3 is a device used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP2D6 gene located on chromosome 22 from genomic DNA extracted from EDTA and citrate anticoagulated whole blood samples.

4 manufacturers with a similar name

Learn more about the data here

  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    Note published by the authorities from the Netherlands: This message is a warning from the manufacturer. After placing a medical device on the market, the manufacturer is obliged to follow the device and, where necessary, to improve it. When there is a risk for the user, the manufacturer must take action. The manufacturer informs users and the inspection of this action with a warning (Field Safety Notice). See also medical device warnings. This is part of the supervision of medical technology.
  • Source
    IGJ
  • Manufacturer Address
    Luminex Corporation, 12212 Technology Blvd, Austin TX 78727-6101
  • Manufacturer Parent Company (2017)
  • Source
    USFDA