Alinity i Anti-CCP Reagent Kit - ARCSA Registration d5b6811245b809a1cf7645e4c71786ba
Access comprehensive regulatory information for Alinity i Anti-CCP Reagent Kit in the Ecuador medical device market through Pure Global AI's free database. This II medical device is registered under ARCSA ID d5b6811245b809a1cf7645e4c71786ba 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 ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CIA) USED FOR THE SEMI-QUANTITATIVE DETERMINATION OF SPECIFIC IGG CLASS AUTOANTIBODIES AGAINST CYCLIC CITRULLINATED PEPTIDE (CCP) IN HUMAN SERUM OR PLASMA IN THE ALINITY I ANALYZER. THE ALINITY I ANTI-CCP ASSAY IS USED AS AN AID IN THE DIAGNOSIS OF RHEUMATOID ARTHRITIS (RA) AND SHOULD BE USED IN CONJUNCTION WITH OTHER CLINICAL INFORMATION.