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COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test Kit - ARCSA Registration feae2982328d2e1a1c0a85efb2a4145d

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 feae2982328d2e1a1c0a85efb2a4145d and manufactured by WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.. The device was registered on May 27, 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
feae2982328d2e1a1c0a85efb2a4145d
COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test Kit
ARCSA ID: feae2982328d2e1a1c0a85efb2a4145d
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Pricing
Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Brand Name
EDiagnosis
Commercial Name
22-339 IVD Reagents/Testing Kits, Molecular Assay, Infection, Virus, Severe Acute Respiratory Sindorme Coronavirus, RNA
Registration Information
Analysis ID
feae2982328d2e1a1c0a85efb2a4145d
Registration Date
May 27, 2020
Expiration Date
May 27, 2025
Product Use

THIS KIT IS USED FOR THE QUALITATIVE DETECTION OF INHUMAN SERUM, PLASMA, OR WHOLE BLOOD OF THE IGM/IGG SARS-COV-2 ANTIBODY (INCLUDING PERIPHERAL BLOOD) IN VITRO.

Manufacturer
City
WUHAN
Country
CHINA
Address
3, 1F (3) WORKSHOP, BUILDING 25, PHASE 3.1, WUHAN OPTICS VALLEY INTERNATIONAL BIOMEDICAL ENTERPRISE ACCELERATOR, NO. 388, GAOXIN 2ND ROAD, DONGHU NEW TECHNOLOGY DEVELOPMENT ZONE, WUHAN CHINA
Product Owner
Name
WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Country
CHINA
Authorized Representative
Address
CIUDADELA: LOS VERGELES STREET: AV. FRANCISCO DE ORELLANA NUMBER: PLOT 1 BLOCK: 227
Phone
42187362