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T-Track® TB Quant PCR - ARCSA Registration 30bbf456a806c5dca20463c20b45bcf3

Access comprehensive regulatory information for T-Track® TB Quant PCR in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 30bbf456a806c5dca20463c20b45bcf3 and manufactured by MIKROGEN GMBH. The device was registered on April 30, 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.

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ARCSA Official Data
III
30bbf456a806c5dca20463c20b45bcf3
T-Track® TB Quant PCR
ARCSA ID: 30bbf456a806c5dca20463c20b45bcf3
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Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Brand Name
Microgenic
Commercial Name
19-564 IVD Reagents/Kits, Molecular Assay, Infection, Bacteria, Mycobacterium tuberculosis
Registration Information
Analysis ID
30bbf456a806c5dca20463c20b45bcf3
Registration Date
April 30, 2023
Expiration Date
April 30, 2028
Product Use

IN VITRO QUALITATIVE DIAGNOSTIC TEST TO ANALYZE THE RESPONSE OF IMMUNE CELLS TO STIMULATION WITH THE ESAT-6 AND CFP-10 PROTEINS OF M. TUBERCULOSIS, PERFORMED WITH STABILIZED RNA, GENERATED BY T-TRACK® TB STIMULATION, BASED ON THE DETERMINATION OF THE RELATIVE EXPRESSION OF THE IFNG, CXCL10 AND RPLP0 MARKERS, BY RT-QPCR.

Manufacturer
City
NEURIED
Country
GERMANY
Address
FLORIANSBOGEN 2-4, 82061 NEURIED, GERMANY
Product Owner
Name
MIKROGEN GMBH
Country
GERMANY
Authorized Representative
Address
AV. EUGENIO ESPEJO 2410 VIA A TANDA NAYON, PLAZA DEL RANCHO
Phone
987070898