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MYOGLOBIN/CK-MB/TROPONIN I COMBO RAPID TEST CASSETTE (SANGRE/SUERO/PLASMA) - COFEPRIS Registration 577R2018 SSA

Access comprehensive regulatory information for MYOGLOBIN/CK-MB/TROPONIN I COMBO RAPID TEST CASSETTE (SANGRE/SUERO/PLASMA) (MYOGLOBIN/CK-MB/TROPONIN I COMBO RAPID TEST CASSETTE (SANGRE/SUERO/PLASMA)) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 577R2018 SSA and manufactured by AMUNET, S.A. DE C.V.. The device was registered on February 27, 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 I
577R2018 SSA
MYOGLOBIN/CK-MB/TROPONIN I COMBO RAPID TEST CASSETTE (SANGRE/SUERO/PLASMA)
COFEPRIS Analysis ID: 577R2018 SSA
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Product Use / Uso del Producto
Spanish

LA MYOGLOBIN/CK-MB/TROPONIN I COMBO RAPID TEST CASSETTE ES UN DISPOSITIVO INDICADO PARA LA DETECCIร“N CUALITATIVA DE MYOGLOBIN/CK-MB AND CARDIAC TROPONIN I (CTNL) HUMANA EN LA SANGRE, SUERO O PLASMA COMO AYUDA EN EL DIAGNร“STICO DE INFARTO DE MIOCARDIO (IM)

English

THE MYOGLOBIN/CK-MB/TROPONIN I COMBO RAPID TEST CASSETTE IS A DEVICE INDICATED FOR THE QUALITATIVE DETECTION OF HUMAN MYOGLOBIN/CK-MB AND CARDIAC TROPONIN I (CTNL) IN BLOOD, SERUM OR PLASMA AS AN AID IN THE DIAGNOSIS OF MYOCARDIAL INFARCTION (MI)

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 RรPIDA COMBINADA DE CREATINACINASA MB, MIOGLOBINA Y TROPONINA I
Trade Name (English)
COMBINED RAPID TEST OF CREATINE KINASE MB, MYOGLOBIN AND TROPONIN I
Registration Information
Analysis ID
577R2018 SSA
Registration Date
February 27, 2018
Manufacturer / Fabricante
Name (Spanish)
AMUNET, S.A. DE C.V.
Name (English)
AMUNET, S.A. DE C.V.