Mexico COFEPRIS registration 3R2019 SSA

CERA-STATTM HBA1C TEST KIT

EN: CERA-STATTM HBA1C TEST KIT
Mexico flagMexico·Clase I·III. DIAGNOSTIC AGENTS·DISTRIBUIDORA QUÍMICA INTEGRAL, S.A. DE C.V.·Registered January 14, 2019
Product Use / Uso del Producto
Spanish

EL KIT DE PRUEBA DE HBA1C CERA-STATTM ESTÁ DESTINADO PARA LA DETERMINACIÓN CUANTITATIVA DE HEMOGLOBINA GLUCOSILADA EN SANGRE HUMANA. TAMBIÉN PROPORCIONA EL VALOR PROMEDIO DE LA GLUCOSA (EAG). AGENTE DE DIAGNÓSTICO PARA USO IN VITRO.

English

THE CERA-STATTM HBA1C TEST KIT IS INTENDED FOR THE QUANTITATIVE DETERMINATION OF GLYCOSYLATED HEMOGLOBIN IN HUMAN BLOOD. IT ALSO PROVIDES THE AVERAGE GLUCOSE VALUE (EAG). DIAGNOSTIC AGENT FOR IN VITRO USE.

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)
KIT PARA LA DETERMINACIÓN DE HBA1C EN SANGRE HUMANA
Trade Name (English)
KIT FOR THE DETERMINATION OF HBA1C IN HUMAN BLOOD
Registration information
Analysis ID
3R2019 SSA
Registration Date
January 14, 2019
Manufacturer / Fabricante
Name (English)
DISTRIBUIDORA QUÍMICA INTEGRAL, S.A. DE C.V.
About this record

Access comprehensive regulatory information for CERA-STATTM HBA1C TEST KIT (CERA-STATTM HBA1C TEST KIT) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 3R2019 SSA and manufactured by DISTRIBUIDORA QUÍMICA INTEGRAL, S.A. DE C.V.. The device was registered on January 14, 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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