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DIINSEL TROPONIN I DIAGNOSTICTEST - COFEPRIS Registration 1107R2021 SSA

Access comprehensive regulatory information for DIINSEL TROPONIN I DIAGNOSTICTEST (DIINSEL TROPONIN I DIAGNOSTICTEST) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1107R2021 SSA and manufactured by DIINSEL, S.A. DE C.V.. The device was registered on December 07, 2021.

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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COFEPRIS Official Data
Clase I
1107R2021 SSA
DIINSEL TROPONIN I DIAGNOSTICTEST
COFEPRIS Analysis ID: 1107R2021 SSA
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Product Use / Uso del Producto
Spanish

ELDIINSELTROPONINIDIAGNOSTICTEST,ESUN INMUNOANÁLISIS CUALITATIVO RÁPIDOPARA LA DETECCIÓN DE LA TROPONINA ICARDÍACA EN MUESTRAS DE SANGRECOMPLETA, SUERO O PLASMA DE SERESHUMANOS. ESTE KIT ESTA DISEÑADO PARAUTILIZARSE COMO UN APOYO EN ELDIAGNÓSTICO DEL INFARTO AL MIOCARDIO(MI).

English

ELDIINSELTROPONINIDIAGNOSTICTEST, IS A RAPID QUALITATIVE IMMUNOASSAY FOR THE DETECTION OF ICARDIAC TROPONIN IN WHOLE BLOOD, SERUM OR PLASMA SAMPLES FROM HUMANS. THIS KIT IS DESIGNED TO BE USED AS A SUPPORT IN THE DIAGNOSIS OF MYOCARDIAL INFARCTION (MI).

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
III. AGENTES DE DIAGNÓSTICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
PRUEBA RÁPIDA PARA DETECCIÓN DETROPONINA CARDIACA EN SANGRE
Trade Name (English)
RAPID TEST FOR CARDIAC BLOOD DETECTION OF TROPONIN
Registration Information
Analysis ID
1107R2021 SSA
Registration Date
December 07, 2021
Manufacturer / Fabricante
Name (Spanish)
DIINSEL, S.A. DE C.V.
Name (English)
DIINSEL, S.A. DE C.V.