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WL Check SARS-CoV-2 Ag - ARCSA Registration 3831318e1ac84a9a5b55013740af6dfa

Access comprehensive regulatory information for WL Check SARS-CoV-2 Ag in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 3831318e1ac84a9a5b55013740af6dfa and manufactured by WIENER LABORATORIES S.A.I.C. The device was registered on July 21, 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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III
3831318e1ac84a9a5b55013740af6dfa
WL Check SARS-CoV-2 Ag
ARCSA ID: 3831318e1ac84a9a5b55013740af6dfa
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Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Brand Name
Wiener lab.
Commercial Name
64787-SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), rapid.
Sterilization Method
IMMUNO- HISTOCHEMISTRY AND CYTOCHEMISTRY
Registration Information
Analysis ID
3831318e1ac84a9a5b55013740af6dfa
Registration Date
July 21, 2022
Expiration Date
July 21, 2027
Creation Date
July 21, 2022
Product Use

IMMUNOCHROMATOGRAPHIC ASSAY FOR THE QUALITATIVE DETECTION OF ANTIGENS OF THE NUCLEOCAPSIDE OF THE SARS-COV-2 VIRUS IN SAMPLES OF NASOPHARYNGEAL OR NASAL SWABS. USE BY HEALTHCARE PROFESSIONALS IN SPECIALIZED LABORATORIES

Manufacturer
City
SANTA FE
Country
ARGENTINA
Address
MAIPU N°2571, ROSARIO, PROVINCE OF SANTA FE – ARGENTINA
Product Owner
Name
WIENER LABORATORIES S.A.I.C
Country
ARGENTINA
Authorized Representative
Address
MARISCAL SUCRE STREET: AV RIO AMAZONAS NUMBER: E4-69INTERSECTION: N19 AV PATRIA
Phone
22562680