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SET DE REACTIVOS PARAGLICOHEMOGLOBINA POINTESCIENTIFIC - COFEPRIS Registration 599R2022 SSA

Access comprehensive regulatory information for SET DE REACTIVOS PARAGLICOHEMOGLOBINA POINTESCIENTIFIC (POINTESCIENTIFIC PARAGLYCOHEMOGLOBIN REAGENT SET) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 599R2022 SSA and manufactured by DICIPA, S.A. DE C.V.. The device was registered on July 12, 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
599R2022 SSA
SET DE REACTIVOS PARAGLICOHEMOGLOBINA POINTESCIENTIFIC
COFEPRIS Analysis ID: 599R2022 SSA
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Product Use / Uso del Producto
Spanish

ELDISPOSITIVOESTÁINDICADOPARALADETERMINACIÓNCUANTITATIVADEGLICOHEMOGLOBINA(HBA1)PRESENTEEN LA SANGRE CON EL MÉTODO DE RESINA DEINTERCAMBIO CATIÓNICO. EL ANÁLISIS SE USA EN LAMONITORIZACÓNDELAGLUCOSAALARGOPLAZO,ENLASPERSONAS CON DIABETES MELLITUS. AGENTE DEDIAGNÓSTICOPARAUSOINVITRO.PARAUSOEXCLUSIVOENLABORATORIOS CLÍNICOS O DE GABINETE.

English

THE DEVICE IS INDICATED FOR THE QUANTITATIVE DETERMINATION OF GLYCOHEMOGLOBIN (HBA1) PRESENT IN THE BLOOD WITH THE CATION EXCHANGE RESIN METHOD. THE ANALYSIS IS USED IN LONG-TERM GLUCOSE MONITORING IN PEOPLE WITH DIABETES MELLITUS. DIAGNOSTIC AGENTFORUSEINVITRO. FOR EXCLUSIVE USE IN CLINICAL OR CABINET LABORATORIES.

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
III. AGENTES DEDIAGNÓSTICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
PRUEBA PARA LADETERMINACIÓN DEGLICOHEMOGLOBINA (HBA 1)
Trade Name (English)
GLYCOHEMOGLOBIN (HBA 1) TEST
Registration Information
Analysis ID
599R2022 SSA
Registration Date
July 12, 2022
Manufacturer / Fabricante
Name (Spanish)
DICIPA, S.A. DE C.V.
Name (English)
DICIPA, S.A. DE C.V.