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ExAmplex Influenza A/B SARS-CoV-2 PCR kit - ARCSA Registration 57f932e18ecb54b322ea260202c5a6d5

Access comprehensive regulatory information for ExAmplex Influenza A/B SARS-CoV-2 PCR kit in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 57f932e18ecb54b322ea260202c5a6d5 and manufactured by BODITECH WITH INC.. The device was registered on March 03, 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
57f932e18ecb54b322ea260202c5a6d5
ExAmplex Influenza A/B SARS-CoV-2 PCR kit
ARCSA ID: 57f932e18ecb54b322ea260202c5a6d5
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Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Commercial Name
19-242 IVD Reagents/Kits, Molecular Assay, Infection, Viruses
Registration Information
Analysis ID
57f932e18ecb54b322ea260202c5a6d5
Registration Date
March 03, 2022
Expiration Date
March 03, 2027
Product Use

DIFFERENTIATION OF INFLUENZA A, INFLUENZA B AND / OR SARS-COV-2 INFECTION OR THE RESPECTIVE DETECTION OF EACH VIRUS IN NASOPHARYNGEAL SWABS / OROPHARYNGEAL SWABS / BRONCHOALVEOLAR LAVAGE

Manufacturer
City
CHUNCHEON, GANGWON-DO
Country
KOREA, REPUBLIC OF
Address
43, GEODUDANJI L-GIL, DONGNAE-MYEON, CHUNCHEON-SI, GANGWON-DO, 24398
Product Owner
Name
BODITECH WITH INC.
Country
KOREA, REPUBLIC OF
Authorized Representative
Address
COOPERATIVA VIVIENDA GUAYAQUIL, AVENIDA JUAN TANCA MARENGO, MANZANA 21
Phone
42233672