Mexico COFEPRIS registration 2444R2018 SSA

FINECARE™ CRP/PCT RAPID QUANTITATIVE TEST

EN: FINECARE™ CRP/PCT RAPID QUANTITATIVE TEST
Mexico flagMexico·Clase II·III. DIAGNOSTIC AGENTS·DISTRIBUIDORA QUÍMICA INTEGRAL, S.A. DE C.V.·Registered October 24, 2018
Product Use / Uso del Producto
Spanish

LA PRUEBA CUANTITATIVA RÁPIDA DE PCR/PCT DE THE FINECARETM ES UN INMUNOENSAYO DE FLUORESCENCIA UTILIZADO JUNTO CON EL SISTEMA FIA FINECARETM, PARA LA DETERMINACIÓN CUANTITATIVA DE LA PROTEÍNA C REACTIVA (PCR) Y LA PROCALCITONINA (PCT) EN SANGRE COMPLETA,

English

THE FINECARETM QUANTITATIVE RAPID PCR/PCT TEST IS A FLUORESCENCE IMMUNOASSAY USED IN CONJUNCTION WITH THE FINECARETM FIA SYSTEM, FOR THE QUANTITATIVE DETERMINATION OF C-REACTIVE PROTEIN (CRP) AND PROCALCITONIN (PCT) IN WHOLE BLOOD,

Device classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
III. AGENTES DE DIAGNÓSTICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
CARTUCHO DE PRUEBA PARA LA CUANTIFICACION DE PCR/PCT
Trade Name (English)
TEST CARTRIDGE FOR PCR/PCT QUANTIFICATION
Registration information
Analysis ID
2444R2018 SSA
Registration Date
October 24, 2018
Manufacturer / Fabricante
Name (English)
DISTRIBUIDORA QUÍMICA INTEGRAL, S.A. DE C.V.
About this record

Access comprehensive regulatory information for FINECARE™ CRP/PCT RAPID QUANTITATIVE TEST (FINECARE™ CRP/PCT RAPID QUANTITATIVE TEST) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 2444R2018 SSA and manufactured by DISTRIBUIDORA QUÍMICA INTEGRAL, S.A. DE C.V.. The device was registered on October 24, 2018.

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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