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9b8b9bbb8a71fe02bd34978477ab396b

Access HAV IgM (Reagent Pack)

BECKMAN COULTER, INC.·III·Ecuador ARCSA·Registered May 07, 2023
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
9b8b9bbb8a71fe02bd34978477ab396b
Registration date
May 07, 2023
Expiration date
May 07, 2028
Manufacturer
Name
BECKMAN COULTER, INC.
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
Name
FRISONEX FRISON IMPORTADORA EXPORTADORA CIA. LTDA.
Address
LAS AVELLANAS STREET E2-25 AND JUNCAL
Phone
23971600
Product use

DETECTION OF HEPATITIS A VIRUS IGM ANTIBODIES IN HUMAN SERUM AND PLASMA USING ACCESS IMMUNOASSAY SYSTEMS.

About this record

Access comprehensive regulatory information for Access HAV 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 9b8b9bbb8a71fe02bd34978477ab396b 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.