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Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit - ARCSA Registration 8df03dc5453a40c4cbb114797a5afad3

Access comprehensive regulatory information for Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit in the Ecuador medical device market through Pure Global AI's free database. This MODERADO ALTO NIVEL III medical device is registered under ARCSA ID 8df03dc5453a40c4cbb114797a5afad3 and manufactured by MEDICALSYSTEM BIOTECHNOLOGY CO., LTD.. The device was registered on April 10, 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
MODERADO ALTO NIVEL III
8df03dc5453a40c4cbb114797a5afad3
Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit
ARCSA ID: 8df03dc5453a40c4cbb114797a5afad3
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Device Classification
Risk Class
MODERADO ALTO NIVEL III
Product Type
In Vitro Diagnostic
Brand Name
MedicalSystem
Commercial Name
22-339 Reagents/Kits for IVD Assays, Molecular Assay, Infection, Virus, Severe Acute Respiratory Syndrome Coronavirus, RNA.
Registration Information
Analysis ID
8df03dc5453a40c4cbb114797a5afad3
Registration Date
April 10, 2020
Expiration Date
April 10, 2025
Product Use

IT IS INTENDED FOR THE QUALITATIVE DETECTION OF THE NOVEL CORONAVIRUS ANTIGM AND IGG 2019 ANTIBODIES IN SERUM, PLASMA, FINGER BLOOD OR WHOLE BLOOD SAMPLES FROM PATIENTS WITH PNEUMONITIS, OR SUSPECTED CASES.

Manufacturer
City
NINGBO
Country
CHINA
Address
Nº 299, QUIMING SOUTH ROAD, YINZHOU DISTRICT, 315104, NINGBO, CHINA
Product Owner
Name
MEDICALSYSTEM BIOTECHNOLOGY CO., LTD.
Country
CHINA
Authorized Representative
Address
MARIANO TURREY N45-217 AND MARCOS JOFFRE
Phone
6041486