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Access CMV IgM (Reagent Pack) - ARCSA Registration c524aab720bf56e6bbe2fe4c9d987961

Access comprehensive regulatory information for Access CMV IgM (Reagent Pack) in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID c524aab720bf56e6bbe2fe4c9d987961 and manufactured by BECKMAN COULTER, INC.. The device was registered on May 07, 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
III
c524aab720bf56e6bbe2fe4c9d987961
Access CMV IgM (Reagent Pack)
ARCSA ID: c524aab720bf56e6bbe2fe4c9d987961
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Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Brand Name
BECKMAN COULTER
Commercial Name
17-077 IVD Reagents/Testing Kits, Serology, Viruses
Registration Information
Analysis ID
c524aab720bf56e6bbe2fe4c9d987961
Registration Date
May 07, 2023
Expiration Date
May 07, 2028
Product Use

QUALITATIVE DETECTION OF CYTOMEGALOVIRUS (CMV) IGM ANTIBODIES IN HUMAN SERUM AND PLASMA (EDTA, HEPARIN) USING ACCESS IMMUNOASSAY SYSTEMS.

Manufacturer
City
BREA
Country
UNITED STATES
Address
250 S. KRAEMER BLVD BREA, CA USA 92821
Product Owner
Name
BECKMAN COULTER, INC.
Country
UNITED STATES
Authorized Representative
Address
LAS AVELLANAS STREET E2-25 AND JUNCAL
Phone
23971600