Alinity i Anti-CCP Reagent Kit
- Risk class
- II
- Product type
- In Vitro Diagnostic
- Brand name
- Architect, Alinity i
- Commercial name
- 19-085 IVD Reagents/Assay Kits, Immunoassay
- Analysis ID
- d5b6811245b809a1cf7645e4c71786ba
- Registration date
- November 27, 2023
- Expiration date
- November 27, 2028
- City
- DUNDEE
- Country
- UNITED KINGDOM OF GREAT BRITAIN
- Address
- LUNA PLACE, THE TECHNOLOGY PARK, DUNDEE DD2 1XA UNITED KINGDOM
- Name
- ABBOTT GMBH
- Country
- GERMANY
- Address
- AV. REPUBLICA DEL SALVADOR N34-493 AND PORTUGAL GIBRALTAR BUILDING 10TH FLOOR
- Phone
- 23992500
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.
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.