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ROCHE CARDIAC POC TROPONIN T - COFEPRIS Registration 1366R2019 SSA

Access comprehensive regulatory information for ROCHE CARDIAC POC TROPONIN T (ROCHE CARDIAC POC TROPONIN T) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1366R2019 SSA and manufactured by PRODUCTOS ROCHE, S.A. DE C.V.. The device was registered on July 17, 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
1366R2019 SSA
ROCHE CARDIAC POC TROPONIN T
COFEPRIS Analysis ID: 1366R2019 SSA
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Product Use / Uso del Producto
Spanish

PRUEBA INMUNOLร“GICA CUANTITATIVA PARA LA DETECCIร“N DE LA TROPONINA T CARDรACA EN SANGRE VENOSA HEPARINIZADA EMPLEANDO LOS SISTEMAS ROCHE. LA PRUEBA CONSTITUYE UNA AYUDA EN EL DIAGNร“STICO PRECOZ DEL INFARTO DE MIOCARDIO AGUDO Y EN LA IDENTIFICACIร“N DE PACI

English

QUANTITATIVE IMMUNOLOGICAL TEST FOR THE DETECTION OF CARDIAC TROPONIN T IN HEPARINIZED VENOUS BLOOD USING ROCHE SYSTEMS. THE TEST IS AN AID IN THE EARLY DIAGNOSIS OF ACUTE MYOCARDIAL INFARCTION AND IN THE IDENTIFICATION OF PACI

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
III. AGENTES DE DIAGNร“STICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
PRUEBA PARA LA DETECCIร“N DE LA TROPONINA T CARDรACA.
Trade Name (English)
CARDIAC TROPONIN T TEST.
Registration Information
Analysis ID
1366R2019 SSA
Registration Date
July 17, 2019
Manufacturer / Fabricante
Name (English)
PRODUCTOS ROCHE, S.A. DE C.V.