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IMMUNOLOGY KIT NEURON-SPECIFIC ENOLASE NSE (CLIA) - COFEPRIS Registration 2224R2021 SSA

Access comprehensive regulatory information for IMMUNOLOGY KIT NEURON-SPECIFIC ENOLASE NSE (CLIA) (IMMUNOLOGY KIT NEURON-SPECIFIC ENOLASE NSE (CLIA)) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 2224R2021 SSA and manufactured by MINDRAY MEDICALMÉXICO, S. DE R.L. DEC.V.. The device was registered on December 30, 2021.

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
2224R2021 SSA
IMMUNOLOGY KIT NEURON-SPECIFIC ENOLASE NSE (CLIA)
COFEPRIS Analysis ID: 2224R2021 SSA
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Product Use / Uso del Producto
Spanish

EL ENSAYO NSE DE LA SERIE CL ES UNINMUNOENSAYO QUIMIOLUMINISCENTE(CLIA) PARA LA DETERMINACIÓNCUANTITATIVA DE LA ENOLASA ESPECÍFICA DE NEURONAS (NSE) EN PLASMA O SUEROHUMANO. AGENTE DE DIAGNÓSTICO INVITRO PARA USO EXCLUSIVO ENLABORATORIO CLÍNICO O DE GABINETE.

English

THE CL SERIES NSE ASSAY IS A CHEMILUMINESCENT IMMUNOASSAY (CLIA) FOR THE QUANTITATIVE DETERMINATION OF NEURON-SPECIFIC ENOLASE (NSE) IN PLASMA OR HUMAN SERUM. INVITRO DIAGNOSTIC AGENT FOR EXCLUSIVE USE IN CLINICAL LABORATORY OR CABINET.

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)
REACTIVOPARALADETERMINACIÓNDELAENOLASA ESPECIFICA DE NEURONAS
Trade Name (English)
REAGENT FOR THE DETERMINATION OF AENOLASA SPECIFIC NEURONS
Registration Information
Analysis ID
2224R2021 SSA
Registration Date
December 30, 2021
Manufacturer / Fabricante
Name (English)
MINDRAY MEDICALMÉXICO, S. DE R.L. DEC.V.