ARCHITECT Anti-CCP Reagent Kit - ARCSA Registration 57faed95c529030dc308c5826d81fff1
Access comprehensive regulatory information for ARCHITECT 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 57faed95c529030dc308c5826d81fff1 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 ARCHITECT ANTI-CCP ASSAY IS A MICROPARTICLE CHEMILUMINOUS IMMUNOASSAY (CMIA) FOR THE SEMI-QUANTITATIVE DETERMINATION OF SPECIFIC IGG CLASS AUTOANTIBODIES AGAINST CYCLIC CITRULLINATED PEPTIDE (CCP) IN HUMAN SERUM OR PLASMA, WITH ARCHITECT ISYSTEM. DETECTION OF ANTI-CCP ANTIBODIES IS USED AS AN AID IN THE DIAGNOSIS OF RHEUMATOID ARTHRITIS (RA) AND SHOULD BE USED IN CONJUNCTION WITH OTHER CLINICAL INFORMATION.