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ANTICUERPOS ANTI-JO1. - COFEPRIS Registration 1010R2019 SSA

Access comprehensive regulatory information for ANTICUERPOS ANTI-JO1. (ANTI-JO ANTIBODIES1.) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1010R2019 SSA and manufactured by BIO SIMEX, S.A. DE C.V.. The device was registered on May 15, 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
1010R2019 SSA
ANTICUERPOS ANTI-JO1.
COFEPRIS Analysis ID: 1010R2019 SSA
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Product Use / Uso del Producto
Spanish

REACTIVOS PARA LA DETERMINACIร“N CUALITATIVA Y CUANTITATIVA DE ANTICUERPOS ANTI-JO1 EN SUERO O PLASMA HUMANOS. AGENTE DE DIAGNร“STICO IN VITRO Y PARA USO EXCLUSIVO EN LABORATORIO CLรNICO O DE GABINETE.

English

REAGENTS FOR THE QUALITATIVE AND QUANTITATIVE DETERMINATION OF ANTI-JO1 ANTIBODIES IN HUMAN SERUM OR PLASMA. IN VITRO DIAGNOSTIC AGENT AND FOR EXCLUSIVE USE IN CLINICAL OR CABINET LABORATORY.

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)
REACTIVOS PARA LA DETERMINACIร“N DE ANTICUERPOS ANTI-JO1. (ANTICUERPOS ASOCIADOS A MIOSITIS)
Trade Name (English)
REAGENTS FOR THE DETERMINATION OF ANTI-JO1 ANTIBODIES. (ANTIBODIES ASSOCIATED WITH MYOSITIS)
Registration Information
Analysis ID
1010R2019 SSA
Registration Date
May 15, 2019
Manufacturer / Fabricante
Name (English)
BIO SIMEX, S.A. DE C.V.