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SARS-CoV-2 Antibody Test - ARCSA Registration b15aab46799c3fae1b16f09c3d5d39c9

Access comprehensive regulatory information for SARS-CoV-2 Antibody Test in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID b15aab46799c3fae1b16f09c3d5d39c9 and manufactured by BEIJING LEPU MEDICAL TECHNOLOGY CO. LTD.. The device was registered on June 19, 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
b15aab46799c3fae1b16f09c3d5d39c9
SARS-CoV-2 Antibody Test
ARCSA ID: b15aab46799c3fae1b16f09c3d5d39c9
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Pricing
Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Brand Name
"LEPU MEDICAL"; "LECCURATE"
Commercial Name
22-441 IVD Reagents/Kits, Serology, Virus, CoronavirusAssociated with Acute Respiratory Syndrome, IgG Antibodies
Registration Information
Analysis ID
b15aab46799c3fae1b16f09c3d5d39c9
Registration Date
June 19, 2020
Expiration Date
June 19, 2025
Product Use

IT IS USED FOR THE QUALITATIVE DETECTION OF IGG/IGM ANTIBODIES OF THE NOVEL CORONAVIRUS IN HUMANS.

Manufacturer
City
BEIJING
Country
CHINA
Address
BUILDING 7-1 , N0.37 CHAOQIAN ROAD CHANGPING DISTRICT 102200 BEIJING CHINA
Product Owner
Name
BEIJING LEPU MEDICAL TECHNOLOGY CO. LTD.
Country
CHINA
Authorized Representative
Address
ROAD: VIA A LA COSTA KM: 11.5 CDLA. TORRES DEL SALADO, MZ. 46 , SEVENTH STREET.
Phone
45056979