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CREATINE KINASE-MB RAPIDTEST - COFEPRIS Registration 362R2022 SSA

Access comprehensive regulatory information for CREATINE KINASE-MB RAPIDTEST (CREATINE KINASE-MB RAPIDTEST) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 362R2022 SSA and manufactured by DIINSEL, S.A. DE C.V.. The device was registered on May 12, 2022.

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
362R2022 SSA
CREATINE KINASE-MB RAPIDTEST
COFEPRIS Analysis ID: 362R2022 SSA
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Product Use / Uso del Producto
Spanish

ELDISPOSITIVOCREATINEKINASE-MBRAPIDTESTESUNINMUNOENSAYO CROMATOGRÁFICO RÁPIDO PARA LADETECCIÓNCUALITATIVADELACREATININAQUINASAMBHUMANAENSANGRECOMPLETA,SUEROOPLASMACOMOAYUDA EN EL DIAGNÓSTICO DE INFARTO DE MIOCARDIO (IM).

English

THE CREATINEKINASE-MBRAPIDTEST DEVICE IS A RAPID CHROMATOGRAPHIC IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF HUMAN AMBIN CREATININE KINASE IN WHOLE 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 DIAGNÓSTICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
PRUEBA RÁPIDA PARADETECCIÓN DE CREATINAQUINASA
Trade Name (English)
RAPID TEST FOR CREATINE KINASE
Registration Information
Analysis ID
362R2022 SSA
Registration Date
May 12, 2022
Manufacturer / Fabricante
Name (Spanish)
DIINSEL, S.A. DE C.V.
Name (English)
DIINSEL, S.A. DE C.V.