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SERUM PROTEIN MULTI-CALIBRATOR 1 - ARCSA Registration b57a6331ea2cfc25db00f6c0b26c55c8

Access comprehensive regulatory information for SERUM PROTEIN MULTI-CALIBRATOR 1 in the Ecuador medical device market through Pure Global AI's free database. This II medical device is registered under ARCSA ID b57a6331ea2cfc25db00f6c0b26c55c8 and manufactured by CLINIQA CORPORATION. The device was registered on May 31, 2022.

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
b57a6331ea2cfc25db00f6c0b26c55c8
SERUM PROTEIN MULTI-CALIBRATOR 1
ARCSA ID: b57a6331ea2cfc25db00f6c0b26c55c8
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Device Classification
Risk Class
II
Product Type
In Vitro Diagnostic
Brand Name
BECKMAN COULTER
Commercial Name
19-954 IVD Reagents/Kits, Immunoassay, Calibration, Protein Assays
Registration Information
Analysis ID
b57a6331ea2cfc25db00f6c0b26c55c8
Registration Date
May 31, 2022
Expiration Date
May 31, 2027
Product Use

PROVIDE ADEQUATE CALIBRATION LEVELS FOR BECKMAN COULTER AU ANALYZERS USING IMMUNOTURBIDIMETRIC ANALYSIS FOR DETERMINATIONS OF IGG, IGA, IGM, C3, C4, TRANSFERRIN, FERRITIN, CRP AND ASO.

Manufacturer
City
SAN MARCOS
Country
UNITED STATES
Address
495 ENTERPRISE STREET, SAN MARCOS, CA 92078 USA.
Product Owner
Name
BECKMAN COULTER, INC.
Country
UNITED STATES
Authorized Representative
Address
LAS AVELLANAS STREET E2-25 AND JUNCAL
Phone
23971600