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Alinity i Anti-CCP Calibrators - ARCSA Registration 2f536160ccc075ec531c49ad72fa4b5e

Access comprehensive regulatory information for Alinity i 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 2f536160ccc075ec531c49ad72fa4b5e 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
2f536160ccc075ec531c49ad72fa4b5e
Alinity i Anti-CCP Calibrators
ARCSA ID: 2f536160ccc075ec531c49ad72fa4b5e
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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
2f536160ccc075ec531c49ad72fa4b5e
Registration Date
November 27, 2023
Expiration Date
November 27, 2028
Product Use

ALINITY I ANTI-CCP CALIBRATORS ARE USED FOR THE CALIBRATION OF THE ALINITY I ANALYZER IN THE SEMI-QUANTITATIVE DETERMINATION OF IGG-SPECIFIC 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