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DYNAMIKER CANDIDA MANNAN ASSAY - COFEPRIS Registration 21R2019 SSA

Access comprehensive regulatory information for DYNAMIKER CANDIDA MANNAN ASSAY (DYNAMIKER CANDIDA MANNAN ASSAY) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 21R2019 SSA and manufactured by INVESTIGACIÓN DIAGNÓSTICA, 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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COFEPRIS Official Data
Clase II
21R2019 SSA
DYNAMIKER CANDIDA MANNAN ASSAY
COFEPRIS Analysis ID: 21R2019 SSA
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Product Use / Uso del Producto
Spanish

DYNAMIKER CANDIDA MANNAN ASSAY SE BASA EN UN ENSAYO COMPETITIVO DE INMUNOABSORCIÓN LIGADO A ENZIMAS (ELISA). SE UTILIZA PARA LA DETECCIÓN CUANTITATIVA DEL ANTÍGENO MANANO DE CANDIDA EN SUERO HUMANO, QUE OFRECE UNA REFERENCIA DE DIAGNÓSTICO PARA LA INFECCI

English

DYNAMIKER CANDIDA MANNAN ASSAY IS BASED ON A COMPETITIVE ENZYME-LINKED IMMUNOSORBENT ASSAY (ELISA). IT IS USED FOR THE QUANTITATIVE DETECTION OF CANDIDA MANNAN ANTIGEN IN HUMAN SERUM, WHICH PROVIDES A DIAGNOSTIC REFERENCE FOR HUMAN SERUM INFECTION.

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)
ENSAYO PARA LA DETECCIÓN CUANTITATIVA DEL ANTÍGENO MANANO DE CANDIDA EN SUERO HUMANO
Trade Name (English)
ASSAY FOR THE QUANTITATIVE DETECTION OF CANDIDA MANNAN ANTIGEN IN HUMAN SERUM
Registration Information
Analysis ID
21R2019 SSA
Registration Date
January 14, 2019
Manufacturer / Fabricante
Name (English)
INVESTIGACIÓN DIAGNÓSTICA, S.A. DE C.V.