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WGene SARS-CoV-2 RT Detection - ARCSA Registration f38b27e455892b6bcfd70cb216f9965a

Access comprehensive regulatory information for WGene SARS-CoV-2 RT Detection in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID f38b27e455892b6bcfd70cb216f9965a and manufactured by WIENER LABORATORIES S.A.I.C. The device was registered on July 13, 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
f38b27e455892b6bcfd70cb216f9965a
WGene SARS-CoV-2 RT Detection
ARCSA ID: f38b27e455892b6bcfd70cb216f9965a
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Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Brand Name
Wiener lab.
Commercial Name
22-339 IVD Reagents/Kits, Molecular Assay, Infection, Virus, Severe Acute Respiratory Syndrome Coronavirus, RNA
Sterilization Method
MOLECULAR DIAGNOSIS
Registration Information
Analysis ID
f38b27e455892b6bcfd70cb216f9965a
Registration Date
July 13, 2022
Expiration Date
July 13, 2027
Creation Date
July 13, 2022
Product Use

METHOD FOR DETECTION OF RNA SEQUENCES OF SARS-COV-2 VIRUS BY POLYMERASE CHAIN REACTION IN REAL TIME

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