Mexico COFEPRIS registration 2445R2018 SSA

FINECARE™ CTNI/CK-MB/MYO RAPID QUANTITATIVE TEST

EN: FINECARE™ CTNI/CK-MB/MYO RAPID QUANTITATIVE TEST
Mexico flagMexico·Clase II·III. DIAGNOSTIC AGENTS·DISTRIBUIDORA QUÍMICA INTEGRAL, S.A. DE C.V.·Registered October 24, 2018
Product Use / Uso del Producto
Spanish

LA PRUEBA TIENE COMO FINALIDAD LA CUANTIFICACIÓN DE LA TROPONINA CARDIACA I (CTNI), CREATINQUINASA-MB Y MIOGLOBINA EN MUESTRAS DE SANGRE COMPLETA, SUERO O PLASMA HUMANO. SOLO PARA USO EN EL EQUIPO FIA SYSTEM AGENTE DE DIAGNÓSTICO IN VITRO PARA USO EXCL

English

THE PURPOSE OF THE TEST IS TO QUANTIFY CARDIAC TROPONIN I (CTNI), CREATINE KINASE-MB AND MYOGLOBIN IN SAMPLES OF WHOLE BLOOD, SERUM OR HUMAN PLASMA. ONLY FOR USE IN THE FIA SYSTEM IN VITRO DIAGNOSTIC AGENT FOR EXCL USE

Device classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
III. AGENTES DE DIAGNÓSTICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
CARTUCHO DE PRUEBA PARA LA CUANTIFICACION DE CTNI/CK-MB/MYO
Trade Name (English)
TEST CARTRIDGE FOR QUANTIFICATION OF CTNI/CK-MB/MYO
Registration information
Analysis ID
2445R2018 SSA
Registration Date
October 24, 2018
Manufacturer / Fabricante
Name (English)
DISTRIBUIDORA QUÍMICA INTEGRAL, S.A. DE C.V.
About this record

Access comprehensive regulatory information for FINECARE™ CTNI/CK-MB/MYO RAPID QUANTITATIVE TEST (FINECARE™ CTNI/CK-MB/MYO RAPID QUANTITATIVE TEST) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 2445R2018 SSA and manufactured by DISTRIBUIDORA QUÍMICA INTEGRAL, S.A. DE C.V.. The device was registered on October 24, 2018.

This page provides complete registration details including product type (III. DIAGNOSTIC AGENTS), manufacturer information, and regulatory compliance data from the official Mexico COFEPRIS medical device database. Pure Global AI offers free access to Mexico's complete medical device registry with bilingual Spanish/English support, helping global MedTech companies navigate COFEPRIS regulations efficiently.

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