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SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) (Saliva/Swab) - ARCSA Registration e574620246098a72a7a70aabc70e436b

Access comprehensive regulatory information for SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) (Saliva/Swab) in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID e574620246098a72a7a70aabc70e436b and manufactured by GENOBIO PHARMACEUTICAL CO., LTD,. The device was registered on September 22, 2021.

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
e574620246098a72a7a70aabc70e436b
SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) (Saliva/Swab)
ARCSA ID: e574620246098a72a7a70aabc70e436b
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Pricing
Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Brand Name
Virusee, Genobio, Era Biology
Commercial Name
50280- In vitro diagnostic kit for SARS coronavirus antigens by rapid immunochromatographic test.
Sterilization Method
INMUNOANALISIS
Registration Information
Analysis ID
e574620246098a72a7a70aabc70e436b
Registration Date
September 22, 2021
Expiration Date
September 22, 2026
Creation Date
September 22, 2021
Product Use

QUALITATIVE DETECTION OF ANTIGENS OF THE PROTEIN OF THE NUCLEOCAPSIDE OF SARS-COV-2 IN SALIVA, NASOPHARYNGEAL SWABS AND OROPHARYNX

Manufacturer
City
TIANJIN
Country
CHINA
Address
2-1, 2, 3-101, NO.2 ZONE, BINLV INDUSTRIAL PARK, BINHAI TOURISM AREA, BINHAI NEW AREA, TIANJIN 300480, CHINA
Product Owner
Name
GENOBIO PHARMACEUTICAL CO., LTD,
Country
CHINA
Authorized Representative
Address
LUIS MORENO MORA AND FRANCISCO MOSCOSO
Phone
2818889