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ARCHITECT Anti-CCP Calibrators - ARCSA Registration f67c5fcf294a2fc8a2907c6d6afd33e2

Access comprehensive regulatory information for ARCHITECT Anti-CCP Calibrators in the Ecuador medical device market through Pure Global AI's free database. This II medical device is registered under ARCSA ID f67c5fcf294a2fc8a2907c6d6afd33e2 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.

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ARCSA Official Data
II
f67c5fcf294a2fc8a2907c6d6afd33e2
ARCHITECT Anti-CCP Calibrators
ARCSA ID: f67c5fcf294a2fc8a2907c6d6afd33e2
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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
f67c5fcf294a2fc8a2907c6d6afd33e2
Registration Date
November 27, 2023
Expiration Date
November 27, 2028
Product Use

ARCHITECT ANTI-CCP CALIBRATORS ARE USED FOR THE CALIBRATION OF THE ARCHITECT ISYSTEM IN THE SEMI-QUANTITATIVE DETERMINATION OF SPECIFIC IGG CLASS AUTOANTIBODIES AGAINST CYCLIC CITRULLINATED PEPTIDE (CCP) IN HUMAN SERUM OR PLASMAS.

Manufacturer
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
Address
AV. REPUBLICA DEL SALVADOR N34-493 AND PORTUGAL GIBRALTAR BUILDING 10TH FLOOR
Phone
23992500