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81fc5c54b2d1e9c2c10727873acee0ed

MolecuTech Real MTBC/NTM

YD DIAGNOSTICS CORP.·III·Ecuador ARCSA·Registered June 02, 2023
Device classification
Risk class
III
Product type
In Vitro Diagnostic
Commercial name
19-564 IVD Reagents/Kits, Molecular Assay, Infection, Bacteria, Mycobacterium tuberculosis
Registration information
Analysis ID
81fc5c54b2d1e9c2c10727873acee0ed
Registration date
June 02, 2023
Expiration date
June 02, 2028
Manufacturer
Name
YD DIAGNOSTICS CORP.
City
YONGIN
Country
KOREA, REPUBLIC OF
Address
76, SEORI-RO, IDONG-EUP, CHEOIN-GUYONGIN-SI, GYEONGGI-DO 17127, REPUBLIC OF KOREA
Product owner
Name
YD DIAGNOSTICS CORP.
Country
KOREA, REPUBLIC OF
Authorized representative
Name
LAB QUALITY S.C.C.
Address
URB BELLAVISTA ALTA 3RD TRANSVERSAL N61-37 AND SABANILLA
Phone
2293537
Product use

FOR THE QUALITATIVE DETECTION OF NUCLEIC ACIDS OF THE MYCOBACTERIUM TUBERCULOSIS COMPLEX (MTB) AND VARIOUS NONTUBERCULOUS MYCOBACTERIA (NMTS) IN SPUTUM, BRONCHIAL WASHING, AND ISOLATES FROM MICROBIOLOGICAL CULTURES

About this record

Access comprehensive regulatory information for MolecuTech Real MTBC/NTM in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 81fc5c54b2d1e9c2c10727873acee0ed and manufactured by YD DIAGNOSTICS CORP.. The device was registered on June 02, 2023.

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.