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Access HBs Ag - ARCSA Registration 4597c14c474c6a8e5a509bce382a8abf

Access comprehensive regulatory information for Access HBs Ag in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 4597c14c474c6a8e5a509bce382a8abf 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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III
4597c14c474c6a8e5a509bce382a8abf
Access HBs Ag
ARCSA ID: 4597c14c474c6a8e5a509bce382a8abf
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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
4597c14c474c6a8e5a509bce382a8abf
Registration Date
May 07, 2023
Expiration Date
May 07, 2028
Product Use

QUALITATIVE DETECTION OF HEPATITIS B VIRUS SURFACE ANTIGEN (HBS AG) IN HUMAN SERUM AND PLASMA 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