ARCHITECT Free T4 Reagent Kit

Fabricant

  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    MHRA

5 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Catalog Number: 7K65-29; 7K65-34; 7K65-39 Batch Number: 65349UI00; 65349UI01; 68194UI00; 68194UI01; 68196UI00; 68196UI01; 71292UI00; 71292UI01; 71374UI00; 71374UI01; 65415UI00; 68241UI01; 70273UI01; 71339UI00; 73200UI01; 74137UI00; 65415UI01; 68241UI00; 70273UI00; 71339UI01; 73200UI00; 74137UI01
  • Description du dispositif
    Diagnostic medical devices in vitro
  • Manufacturer
  • Modèle / numéro de série
    7K65-29; 7K65-34; 7K65-39 | 65349UI00; 65349UI01; 68194UI00; 68194UI01; 68196UI00; 68196UI01; 71292UI00; 71292UI01; 71374UI00; 71374UI01; 65415UI00; 68241UI01; 70273UI01; 71339UI00; 73200UI01; 74137UI00; 65415UI01; 68241UI00; 70273UI00; 71339UI01; 73200UI00; 74137UI01
  • Description du dispositif
    IVD: Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay
  • Manufacturer
  • Modèle / numéro de série
    Model Catalog: 7K65-34 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 7K65-29 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 7K65-39 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Description du dispositif
    ARCHITECT FREE T4 REAGENT
  • Manufacturer