COVID-19 (sars-cov-2) IgM/IgG Antibody Test Kit - ARCSA Registration 0533cca3565d7e3440a2653ce76fe51f
Access comprehensive regulatory information for COVID-19 (sars-cov-2) IgM/IgG Antibody Test Kit in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 0533cca3565d7e3440a2653ce76fe51f and manufactured by WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.. The device was registered on June 16, 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
0533cca3565d7e3440a2653ce76fe51f
COVID-19 (sars-cov-2) IgM/IgG Antibody Test Kit
ARCSA ID: 0533cca3565d7e3440a2653ce76fe51f
Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Commercial Name
22-441 Reagents/Kits for IVD Assays, Serology, Virus, CoronavirusAssociated with Acute Respiratory Syndrome, IgG Antibodies.
Registration Information
Analysis ID
0533cca3565d7e3440a2653ce76fe51f
Registration Date
June 16, 2020
Expiration Date
June 16, 2025
Product Use
FOR IN VITRO DIAGNOSIS.
Manufacturer
City
WUHAN
Country
CHINA
Address
ROOM 3 & 4, 2ND FLOOR, BLDG 25, PHASE 3.1 WUHAN OPTICS VALLEY INTERNATIONAL BIOPHARMACEUTICAL ENTERPRISE ACCELERATOR, NO.388, GAOXIN 2ND RD, EAST LAKE HI-TECH DEVELOPMENT ZONE, 430074 WUHAN HUBEI, P.R. CHINA
Product Owner
Name
WUHAN EASYDIAGNOSIS BIOMEDICINE CO. LTD.
Country
CHINA
Authorized Representative
Address
CITADEL: URDESA CENTRAL STREET: BALSAMOS NUMBER: 108 INTERSECTION: AV. VICTOR EMILIO ESTRADA
Phone
46013946