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SARS-COv-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) - ARCSA Registration 9ccc7f3404e4dc7dbcc7763b1bea569c

Access comprehensive regulatory information for SARS-COv-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 9ccc7f3404e4dc7dbcc7763b1bea569c and manufactured by BEIJING LEPU MEDICAL TECHNOLOGY CO. LTD.. The device was registered on December 17, 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
9ccc7f3404e4dc7dbcc7763b1bea569c
SARS-COv-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)
ARCSA ID: 9ccc7f3404e4dc7dbcc7763b1bea569c
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Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Brand Name
LEPU MEDICAL
Commercial Name
IVD Reagents/Assays, Serology, Viruses, Acute Respiratory Syndrome-Associated Coronavirus, IgG Antibodies
Registration Information
Analysis ID
9ccc7f3404e4dc7dbcc7763b1bea569c
Registration Date
December 17, 2020
Expiration Date
December 17, 2025
Product Use

THE PRODUCT IS DESIGNED FOR THE QUALITATIVE DETECTION OF ANTIGEN AGAINST SARS-COV-2 IN SAMPLES CLINICS (NASAL SWAB).

Manufacturer
City
BEIJING
Country
CHINA
Address
Nº 37 CHAOQIAN ROAD, CHANGPING DISTRICT, BEIJING 102200
Product Owner
Name
BEIJING LEPU MEDICAL TECHNOLOGY CO. LTD.
Country
CHINA
Authorized Representative
Address
AV. MARIANA DE JESUS OE7-02 Y NUNO DE VALDERRAMA
Phone
23517336