2954e6a769f685d7235908e1b93204a0
Access HBc IgM
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
- 2954e6a769f685d7235908e1b93204a0
- Registration date
- May 07, 2023
- Expiration date
- May 07, 2028
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
Product use
DETECTION OF HEPATITIS B VIRUS ANTIGEN IGM ANTIBODIES IN HUMAN SERUM AND PLASMA USING ACCESS IMMUNOASSAY SYSTEMS.
About this record
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.