Mexico COFEPRIS registration 4R2019 SSA

FINECARE™ ONE STEP MAU RAPID QUANTITATIVE TEST

EN: FINECARE™ ONE STEP MAU RAPID QUANTITATIVE TEST
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

LA PRUEBA TIENE COMO FINALIDAD LA DETERMINACIÓN CUANTITATIVA DE LA MICROALBUMINA URINARIA (MAU) EN MUESTRAS DE ORINA HUMANA. AGENTE DE DIAGNÓSTICO IN VITRO PARA USO EN LABORATORIOS CLÍNICOS Y/O DE GABINETE

English

THE PURPOSE OF THE TEST IS THE QUANTITATIVE DETERMINATION OF URINARY MICROALBUMIN (MAU) IN HUMAN URINE SAMPLES. IN VITRO DIAGNOSTIC AGENT FOR USE IN CLINICAL AND/OR CABINET LABORATORIES

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)
CARTUCHO DE PRUEBA PARA LA CUANTIFICACION DE MAU
Trade Name (English)
TEST CARTRIDGE FOR MAU QUANTIFICATION
Registration information
Analysis ID
4R2019 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 FINECARE™ ONE STEP MAU RAPID QUANTITATIVE TEST (FINECARE™ ONE STEP MAU RAPID QUANTITATIVE TEST) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 4R2019 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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