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ichroma ™ Covid-19/FLU Ag (combo) - ARCSA Registration a3835fddea586c77e1de888f57ecd3df

Access comprehensive regulatory information for ichroma ™ Covid-19/FLU Ag (combo) in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID a3835fddea586c77e1de888f57ecd3df and manufactured by BODITECH WITH INC.. The device was registered on May 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
a3835fddea586c77e1de888f57ecd3df
ichroma ™ Covid-19/FLU Ag (combo)
ARCSA ID: a3835fddea586c77e1de888f57ecd3df
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Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Brand Name
i-Chroma
Commercial Name
19-085 IVD Reagents/Assay Kits, Immunoassay
Registration Information
Analysis ID
a3835fddea586c77e1de888f57ecd3df
Registration Date
May 03, 2022
Expiration Date
May 03, 2027
Product Use

SIMULTANEOUS DETERMINATION OF INFLUENZA A, B VIRUS AND / OR INFECTION BY SARS-COV-2 OR THE RESPECTIVE DETECTION OF EACH VIRUS IN NASOPHARYNGEAL SWAB

Manufacturer
City
CHUNCHEON, GANGWON-DO
Country
KOREA, REPUBLIC OF
Address
43, GEODUDANJI 1-GIL, DONGNAE-MYEON, CHUNCHEON-SI, GANGWON DO
Product Owner
Name
BODITECH WITH INC.
Country
KOREA, REPUBLIC OF
Authorized Representative
Address
NEIGHBORHOOD: COOP DE VIVIENDA SERVIDORES Y MANZANA:21 CALLE:AVENIDA JUANTANCA MARENGO, SOLAR 5 INTERSECTION: SN
Phone
42233672