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GLDH3 - COFEPRIS Registration 530R2022 SSA

Access comprehensive regulatory information for GLDH3 (GLDH3) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 530R2022 SSA and manufactured by PRODUCTOSROCHE, S.A. DE C.V.. The device was registered on June 24, 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
530R2022 SSA
GLDH3
COFEPRIS Analysis ID: 530R2022 SSA
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Product Use / Uso del Producto
Spanish

PRUEBAINVITROPARALADETERMINACIÓNCUANTITATIVADE GLUTAMATO DESHIDROGENASA (GLDH) EN SUERO YPLASMAHUMANOSENLOSSISTEMASROCHE. AGENTEDEDIAGNÓSTICOPARAUSOINVITRO. PARAUSOEXCLUSIVOEN LABORATORIOS CLÍNICOS O DE GABINETES.

English

INVITRO TEST FOR THE QUANTITATIVE DETERMINATION OF GLUTAMATE DEHYDROGENASE (GLDH) IN HUMAN SERUM AND PLASMA IN ROCHE SYSTEMS. DIAGNOSTIC AGENTFOR use. FOR USE ONLY IN CLINICAL LABORATORIES OR CABINETS.

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)
REACTIVO PARA LADETERMINACIÓN DEGLUTAMATO DESHIDROGENASA
Trade Name (English)
REAGENT FOR THE DETERMINATION OF GLUTAMATE DEHYDROGENASE
Registration Information
Analysis ID
530R2022 SSA
Registration Date
June 24, 2022
Manufacturer / Fabricante
Name (English)
PRODUCTOSROCHE, S.A. DE C.V.