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SARS-CoV-2 Antibody Test (colloidal gold immunochromatography) - ARCSA Registration c843b0fd5f23c34699e5ffa80e5f6d1b

Access comprehensive regulatory information for SARS-CoV-2 Antibody Test (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 c843b0fd5f23c34699e5ffa80e5f6d1b and manufactured by BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.. The device was registered on June 11, 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
c843b0fd5f23c34699e5ffa80e5f6d1b
SARS-CoV-2 Antibody Test (colloidal gold immunochromatography)
ARCSA ID: c843b0fd5f23c34699e5ffa80e5f6d1b
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Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Commercial Name
22-441 -IVD Reagents/Kits, Serology, Virus, Acute Respiratory Syndrome-Associated Coronavirus, COVID-19 IgG Antibodies
Registration Information
Analysis ID
c843b0fd5f23c34699e5ffa80e5f6d1b
Registration Date
June 11, 2020
Expiration Date
June 11, 2025
Product Use

THE PRODUCT IS USED FOR THE QUALITATIVE DETECTION OF THE CONTENT OF ANTIBODIES AGAINST SARS-COV-2 IN CLINICAL SAMPLES (SERUM / PLASMA / WHOLE BLOOD).

Manufacturer
City
BEIJING
Country
CHINA
Address
BUILDING 7-1 NO. 37 CHAOQIAN ROAD, CHANGPING DISTRICT 102200 BEIJING CHINA
Product Owner
Name
BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Country
CHINA
Authorized Representative
Address
EL ARENAL STREET OE11-192 AND PANAMERICANA NORTE
Phone
23477164