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CTNL/CK-MB/MYO (CARDIAC PANEL) TEST KIT (IMMUNOFLUORESCENCE). - COFEPRIS Registration 2094R2019 SSA

Access comprehensive regulatory information for CTNL/CK-MB/MYO (CARDIAC PANEL) TEST KIT (IMMUNOFLUORESCENCE). (CTNL/CK-MB/MYO (CARDIAC PANEL) TEST KIT (IMMUNOFLUORESCENCE).) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 2094R2019 SSA and manufactured by ATYDE MÉXICO, S.A. DE C.V.. The device was registered on November 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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COFEPRIS Official Data
Clase I
2094R2019 SSA
CTNL/CK-MB/MYO (CARDIAC PANEL) TEST KIT (IMMUNOFLUORESCENCE).
COFEPRIS Analysis ID: 2094R2019 SSA
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Product Use / Uso del Producto
Spanish

KIT PARA DETERMINACIÓN CUANTITATIVA IN VITRO DEL CONTENIDO DE CTNL/CK-MB/MYO (PANEL CARDIACO) EN SUERO HUMANO, PLASMA O SANGRE COMPLETA. AGENTE DE DIAGNÓSTICO IN VITRO. PARA USO EXCLUSIVO DE LABORATORIOS CLÍNICOS O DE GABINETE.

English

KIT FOR QUANTITATIVE IN VITRO DETERMINATION OF CTNL/CK-MB/MYO (CARDIAC PANEL) CONTENT IN HUMAN SERUM, PLASMA OR WHOLE BLOOD. IN VITRO DIAGNOSTIC AGENT. FOR USE OF CLINICAL OR CABINET LABORATORIES ONLY.

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)
REACTIVO PARA LA DETERMINACIÓN DE TROPONINA CARDIACA.
Trade Name (English)
REAGENT FOR THE DETERMINATION OF CARDIAC TROPONIN.
Registration Information
Analysis ID
2094R2019 SSA
Registration Date
November 06, 2019
Manufacturer / Fabricante
Name (English)
ATYDE MÉXICO, S.A. DE C.V.