Liquid Cardiac Control Level 2 and Level 3

  • Modèle / numéro de série
    CQ5053 CQ5052
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Distribution.
  • Description du dispositif
    The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls containing BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T. They have been developed for use in the quality control of BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T assays on various clinical chemistry and immunoassay systems. This in vitro diagnostic device is intended for prescription use only.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Randox Laboratories, 55 The Diamond Road, Antrim United Kingdom
  • Société-mère du fabricant (2017)
  • Source
    USFDA