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IMMUNOGLOBULIN A (IGA) DETECTION KIT (NEPHELOMETRY) - COFEPRIS Registration 2190R2019 SSA

Access comprehensive regulatory information for IMMUNOGLOBULIN A (IGA) DETECTION KIT (NEPHELOMETRY) (IMMUNOGLOBULIN A (IGA) DETECTION KIT (NEPHELOMETRY)) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 2190R2019 SSA and manufactured by ATYDE Mร‰XICO S.A. DE C.V.. The device was registered on November 26, 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
2190R2019 SSA
IMMUNOGLOBULIN A (IGA) DETECTION KIT (NEPHELOMETRY)
COFEPRIS Analysis ID: 2190R2019 SSA
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Product Use / Uso del Producto
Spanish

KIT PARA DETERMINACIร“N CUANTITATIVA IN VITRO DEL CONTENIDO DE IGA EN SUERO HUMANO O PLASMA. AGENTE DE DIAGNร“STICO PARA USO IN VITRO. PARA USO EXCLUSIVO EN LABORATORIOS CLรNICOS O DE GABINETES

English

KIT FOR QUANTITATIVE IN VITRO DETERMINATION OF IGA CONTENT IN HUMAN SERUM OR PLASMA. DIAGNOSTIC AGENT FOR IN VITRO USE. FOR USE IN CLINICAL OR CABINET LABORATORIES ONLY

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)
KIT DE REACTIVOS PARA LA DETERMINACIร“N DE INMUNOGLOBULINA A (IGA).
Trade Name (English)
KIT OF REAGENTS FOR THE DETERMINATION OF IMMUNOGLOBULIN A (IGA).
Registration Information
Analysis ID
2190R2019 SSA
Registration Date
November 26, 2019
Manufacturer / Fabricante
Name (English)
ATYDE MEXICO S.A. DE C.V.