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f194258f6c4c9ff461a235d2e35fc48e

ARCHITECT Anti-CCP Controls

AXIS-SHIELD DIAGNOSTICS LIMITED·II·Ecuador ARCSA·Registered November 27, 2023
Device classification
Risk class
II
Product type
In Vitro Diagnostic
Brand name
Architect, Alinity i
Commercial name
19-085 IVD Reagents/Assay Kits, Immunoassay
Registration information
Analysis ID
f194258f6c4c9ff461a235d2e35fc48e
Registration date
November 27, 2023
Expiration date
November 27, 2028
Manufacturer
Name
AXIS-SHIELD DIAGNOSTICS LIMITED
City
DUNDEE
Country
UNITED KINGDOM OF GREAT BRITAIN
Address
LUNA PLACE, THE TECHNOLOGY PARK, DUNDEE DD2 1XA UNITED KINGDOM
Product owner
Name
ABBOTT GMBH
Country
GERMANY
Authorized representative
Name
ABBOTT LABORATORIOS DEL ECUADOR CIA LTDA
Address
AV. REPUBLICA DEL SALVADOR N34-493 AND PORTUGAL GIBRALTAR BUILDING 10TH FLOOR
Phone
23992500
Product use

ARCHITECT ANTI-CCP CONTROLS ARE USED FOR ASSAY ACCURACY ESTIMATION AND DETECTION OF ARCHITECT ISYSTEM SYSTEMATIC ANALYTICAL DEVIATIONS (REAGENTS, CALIBRATORS AND INSTRUMENT), IN THE SEMI-QUANTITATIVE DETERMINATION OF SPECIFIC IGG CLASS AUTOANTIBODIES AGAINST CYCLIC CITRULLINATED PEPTIDE (CCP) IN HUMAN SERUM OR PLASMA.

About this record

Access comprehensive regulatory information for ARCHITECT 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 f194258f6c4c9ff461a235d2e35fc48e 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.