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REACTIVO PROTEÍNA C REACTIVA OPTILITE® - COFEPRIS Registration 754R2019 SSA

Access comprehensive regulatory information for REACTIVO PROTEÍNA C REACTIVA OPTILITE® (REAGENT PROTEIN C REACTIVE OPTILITE®) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 754R2019 SSA and manufactured by INSUMOS PARA LA SALUD, S.A. DE C.V.. The device was registered on April 10, 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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COFEPRIS Official Data
Clase I
754R2019 SSA
REACTIVO PROTEÍNA C REACTIVA OPTILITE®
COFEPRIS Analysis ID: 754R2019 SSA
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Product Use / Uso del Producto
Spanish

EL REACTIVO PROTEÍNA C REACTIVA OPTILITE®, CON EL CALIBRADOR Y CONTROLES DE PROTEÍNA C REACTIVA OPTILITE®, ESTA DISEÑADO PARA LA CUANTIFICACIÓN IN VITRO DE LA CONCENTRACIÓN DE PROTEÍNA C REACTIVA (CRP) EN SUERO O PLASMA OBTENIDA CON HEPARINA LITIO O EDTA,

English

THE OPTILITE C-REACTIVE PROTEIN REAGENT, WITH THE OPTILITE®® C-REACTIVE PROTEIN CALIBRATOR AND CONTROLS, IS DESIGNED FOR IN VITRO QUANTIFICATION OF THE CONCENTRATION OF C-REACTIVE PROTEIN (CRP) IN SERUM OR PLASMA OBTAINED WITH LITHIUM HEPARIN OR EDTA,

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 LA DETERMINACIÓN DE PROTEÍNA C REACTIVA
Trade Name (English)
REAGENT FOR THE DETERMINATION OF C-REACTIVE PROTEIN
Registration Information
Analysis ID
754R2019 SSA
Registration Date
April 10, 2019
Manufacturer / Fabricante
Name (English)
INSUMOS PARA LA SALUD, S.A. DE C.V.