Access HBc IgM - ARCSA Registration 2954e6a769f685d7235908e1b93204a0
Access comprehensive regulatory information for Access HBc IgM in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 2954e6a769f685d7235908e1b93204a0 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
2954e6a769f685d7235908e1b93204a0
Access HBc IgM
ARCSA ID: 2954e6a769f685d7235908e1b93204a0
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
2954e6a769f685d7235908e1b93204a0
Registration Date
May 07, 2023
Expiration Date
May 07, 2028
Product Use
DETECTION OF HEPATITIS B VIRUS ANTIGEN IGM ANTIBODIES IN HUMAN SERUM AND PLASMA USING ACCESS IMMUNOASSAY SYSTEMS.
Manufacturer
Product Owner
Name
BECKMAN COULTER, INC.
Country
UNITED STATES
Authorized Representative
Address
LAS AVELLANAS STREET E2-25 AND JUNCAL
Phone
23971600