COVID-19 IgG/IgM test rapid immunoassay for COVID-19 infection - ARCSA Registration 8694c86abf0d95ba100c1512bf3a96e1
Access comprehensive regulatory information for COVID-19 IgG/IgM test rapid immunoassay for COVID-19 infection in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 8694c86abf0d95ba100c1512bf3a96e1 and manufactured by GENBODY INC. The device was registered on April 15, 2020.
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
8694c86abf0d95ba100c1512bf3a96e1
COVID-19 IgG/IgM test rapid immunoassay for COVID-19 infection
ARCSA ID: 8694c86abf0d95ba100c1512bf3a96e1
Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Brand Name
GENBODY INC
Commercial Name
22-441- Reagents/Kits for IVD Assays, Serology, Virus, Coronavirus Associated with Acute Respiratory Syndrome, IgG Antibodies.
Registration Information
Analysis ID
8694c86abf0d95ba100c1512bf3a96e1
Registration Date
April 15, 2020
Expiration Date
April 15, 2025
Product Use
TEST CASSETTE IS AN ESSAY
Manufacturer
Name
GENBODY INCCountry
KOREA, REPUBLIC OF
Address
GENBODY BUILDING, 3-18, EOPSEONG 2-GIL, SEOBUK-GU, CHEONAN-SI, CHUNGNAM, 31077, KOREA
Product Owner
Name
GENBODY INC
Country
KOREA, REPUBLIC OF
Authorized Representative