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DIAQUICK CARDIAC COMBO CASSETTE - COFEPRIS Registration 2227R2018 SSA

Access comprehensive regulatory information for DIAQUICK CARDIAC COMBO CASSETTE (DIAQUICK CARDIAC COMBO CASSETTE) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 2227R2018 SSA and manufactured by INVESTIGACIÓN DIAGNÓSTICA, S.A. DE C.V.. The device was registered on September 20, 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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COFEPRIS Official Data
Clase II
2227R2018 SSA
DIAQUICK CARDIAC COMBO CASSETTE
COFEPRIS Analysis ID: 2227R2018 SSA
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Product Use / Uso del Producto
Spanish

EL DIAQUICK CARDIAC COMBO CASSETTE, ES UN INMUNOENSAYO VISUAL RÁPIDO PARA LA DETECCIÓN CUALITATIVA DE MIOGLOBINA HUMANA, CK-MB Y TROPONINA I CARDIACA EN SANGRE TOTAL, SUERO O PLASMA. ESTE KIT ESTÁ DESTINADO PARA USO COMO UNA AYUDA EN EL DIAGNÓSTICO DE INF

English

THE DIAQUICK CARDIAC COMBO CASSETTE IS A RAPID VISUAL IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF HUMAN MYOGLOBIN, CK-MB AND CARDIAC TROPONIN I IN WHOLE BLOOD, SERUM OR PLASMA. THIS KIT IS INTENDED FOR USE AS AN AID IN INF DIAGNOSIS.

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)
PRUEBA RÁPIDA PARA LA DETECCIÓN SIMULTÁNEA DE MIOGLOBINA, CK-MB Y TROPONINA CARDÍACA (CTNL) EN MUEST
Trade Name (English)
RAPID TEST FOR SIMULTANEOUS DETECTION OF MYOGLOBIN, CK-MB AND CARDIAC TROPONIN (CTNL) IN MUEST
Registration Information
Analysis ID
2227R2018 SSA
Registration Date
September 20, 2018
Manufacturer / Fabricante
Name (English)
INVESTIGACIÓN DIAGNÓSTICA, S.A. DE C.V.