Mexico COFEPRIS registration 430R2019 SSA

FINECARE™ CTNI RAPID QUANTITATIVE TEST.

EN: FINECARE™ CTNI RAPID QUANTITATIVE TEST.
Mexico flagMexico·Clase II·III. DIAGNOSTIC AGENTS·DISTRIBUIDORA QUÍMICA INTEGRAL, S.A. DE C.V.·Registered March 06, 2019
Product Use / Uso del Producto
Spanish

LA PRUEBA CUANTITATIVA RÁPIDA DE CTNI DE THE FINECARETM ES UN INMUNOENSAYO DE FLUORESCENCIA UTILIZADO JUNTO CON EL SISTEMA FIA FINECARETM, PARA LA DETERMINACIÓN CUANTITATIVA DE LA TROPONINA CARDIACA I (CTNI) ES SANGRE TOTAL, SUERO O PLASMA HUMANO. AGENTE

English

THE FINECARETM QUANTITATIVE RAPID CTNI TEST IS A FLUORESCENCE IMMUNOASSAY USED IN CONJUNCTION WITH THE FINECARETM FIA SYSTEM, FOR THE QUANTITATIVE DETERMINATION OF CARDIAC TROPONIN I (CTNI) IS HUMAN WHOLE BLOOD, SERUM OR PLASMA. AGENT

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.
Trade Name (English)
TEST CARTRIDGE FOR CTNI QUANTIFICATION.
Registration information
Analysis ID
430R2019 SSA
Registration Date
March 06, 2019
Manufacturer / Fabricante
Name (English)
DISTRIBUIDORA QUÍMICA INTEGRAL, S.A. DE C.V.
About this record

Access comprehensive regulatory information for FINECARE™ CTNI RAPID QUANTITATIVE TEST. (FINECARE™ CTNI 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 430R2019 SSA and manufactured by DISTRIBUIDORA QUÍMICA INTEGRAL, S.A. DE C.V.. The device was registered on March 06, 2019.

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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