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TPO IGG ELISA. - COFEPRIS Registration 2078R2019 SSA

Access comprehensive regulatory information for TPO IGG ELISA. (TPO IGG ELISA.) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 2078R2019 SSA and manufactured by DIAGMEX, S.A. DE C.V.. The device was registered on November 05, 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
2078R2019 SSA
TPO IGG ELISA.
COFEPRIS Analysis ID: 2078R2019 SSA
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Product Use / Uso del Producto
Spanish

ESTร DISEร‘ADO PARA LA DETECCIร“N CUALITATIVA Y SEMI-CUANTITATIVA DE ANTICUERPOS DE CLASE IGG CONTRA LA PEROXIDASA TIROIDEA (TPO) EN SUERO HUMANO. EL SISTEMA DE PRUEBA ESTร DESTINADO PARA SER UTILIZADO COMO AYUDA EN EL DIAGNร“STICO DE ENFERMEDADES TIROIDEAS.

English

IT IS DESIGNED FOR THE QUALITATIVE AND SEMI-QUANTITATIVE DETECTION OF IGG CLASS ANTIBODIES AGAINST THYROID PEROXIDASE (TPO) IN HUMAN SERUM. THE TEST SYSTEM IS INTENDED TO BE USED AS AN AID IN THE DIAGNOSIS OF THYROID DISEASES.

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)
REACTIVO PARA DETECTAR ANTICUERPOS DE CLASE IGG CONTRA PEROXIDASA TIROIDEA (TPO).
Trade Name (English)
REAGENT TO DETECT IGG ANTIBODIES AGAINST THYROID PEROXIDASE (TPO).
Registration Information
Analysis ID
2078R2019 SSA
Registration Date
November 05, 2019
Manufacturer / Fabricante
Name (Spanish)
DIAGMEX, S.A. DE C.V.
Name (English)
DIAGMEX, S.A. DE C.V.