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SARS-CoV-2 Antigen Rapid Test Kits for Self-testing (Colloidal Gold Immunochromatography) - ARCSA Registration db77ea8f20701523da4b887cb395f6cb

Access comprehensive regulatory information for SARS-CoV-2 Antigen Rapid Test Kits for Self-testing (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 db77ea8f20701523da4b887cb395f6cb and manufactured by BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.. The device was registered on September 23, 2022.

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
db77ea8f20701523da4b887cb395f6cb
SARS-CoV-2 Antigen Rapid Test Kits for Self-testing (Colloidal Gold Immunochromatography)
ARCSA ID: db77ea8f20701523da4b887cb395f6cb
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Pricing
Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Brand Name
LEPU MEDICAL
Commercial Name
65454 - SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Sterilization Method
INMUNOCROMATOGRAFIA
Registration Information
Analysis ID
db77ea8f20701523da4b887cb395f6cb
Registration Date
September 23, 2022
Expiration Date
September 23, 2027
Creation Date
September 23, 2022
Product Use

RAPID LATERAL FLOW IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF SARS-COV-2 NUCLEOCAPSID ANTIGENS FROM ANTERIOR NASAL SWABS

Manufacturer
City
BEIJING
Country
CHINA
Address
NO.37 CHAOQIAN ROAD, CHANGPING DISTRICT, BEIJING, 102200, P.R. CHINA
Product Owner
Name
BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Country
CHINA
Authorized Representative
Address
AV. 10 AUGUST AND CZECH
Phone
22927112