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T-Track® TB Stimulation - ARCSA Registration 1dd56f523cea599d4cc3eb53c89e86dd

Access comprehensive regulatory information for T-Track® TB Stimulation in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 1dd56f523cea599d4cc3eb53c89e86dd 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
1dd56f523cea599d4cc3eb53c89e86dd
T-Track® TB Stimulation
ARCSA ID: 1dd56f523cea599d4cc3eb53c89e86dd
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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
1dd56f523cea599d4cc3eb53c89e86dd
Registration Date
April 30, 2023
Expiration Date
April 30, 2028
Product Use

IN VITRO DIAGNOSTIC TEST FOR STIMULATION OF IMMUNE CELLS IN WHOLE BLOOD HEPARINIZED WITH M. TUBERCULOSIS ESAT-6 AND CFP-10 PROTEINS. T-TRACK TB STIMULATION, IN COMBINATION WITH T-TRACK®® TB QUANT PCR AND ASSOCIATED SOFTWARE, IS DESIGNED TO BE USED AS AN AID IN THE DIAGNOSIS OF M. TUBERCULOSIS INFECTION (INCLUDING ACTIVE DISEASE).

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