Alinity i Anti-CCP Controls - ARCSA Registration 5d5bfae72d18a10181e9676573a19f9a
Access comprehensive regulatory information for Alinity i Anti-CCP Controls in the Ecuador medical device market through Pure Global AI's free database. This II medical device is registered under ARCSA ID 5d5bfae72d18a10181e9676573a19f9a and manufactured by AXIS-SHIELD DIAGNOSTICS LIMITED. The device was registered on November 27, 2023.
This page provides complete registration details including product type (In Vitro Diagnostic), manufacturer information, authorized representative details, and regulatory compliance data from the official Ecuador ARCSA medical device database. Pure Global AI offers free access to Ecuador's complete medical device registry.
THE ALINITY I ANTI-CCP CONTROLS ARE USED FOR THE ESTIMATION OF THE ACCURACY OF THE ASSAY AND THE DETECTION OF THE SYSTEMATIC ANALYTICAL DEVIATIONS OF THE ALINITY I ANALYZER (REAGENTS, CALIBRATORS AND INSTRUMENT) IN THE SEMIQUANTITATIVE DETERMINATION OF SPECIFIC IGG CLASS AUTOANTIBODIES AGAINST CYCLIC CITRULLINATED PEPTIDE (CCP) IN HUMAN SERUM OR PLASMAS.