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e64c59d10810dc042ae6f96737a894cf

ExAmplar COVID-19 real-time PCR kit (L)

BODITECH WITH INC.·III·Ecuador ARCSA·Registered March 03, 2022
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
e64c59d10810dc042ae6f96737a894cf
Registration date
March 03, 2022
Expiration date
March 03, 2027
Manufacturer
Name
BODITECH WITH INC.
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
Name
RAPIDIAGNOSTICS S.A.
Address
COOPERATIVA VIVIENDA GUAYAQUIL, AVENIDA JUAN TANCA MARENGO, MANZANA 21
Phone
42233672
Product use

QUALITATIVE OF NOVEL CORONAVIRUS 2019 (COVID-19) IN HUMAN NASOPHARYNGEAL SWABS / OROPHARYNGEAL SWABS / BRONCHOALVEOLAR LAVAGE / SPUTUM

About this record

Access comprehensive regulatory information for ExAmplar COVID-19 real-time PCR kit (L) in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID e64c59d10810dc042ae6f96737a894cf 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.