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AUTOINMUNE EIA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODIES (ASCA) IGA E IGG - COFEPRIS Registration 554R2019 SSA

Access comprehensive regulatory information for AUTOINMUNE EIA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODIES (ASCA) IGA E IGG (AUTOINMUNE EIA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODIES (ASCA) IGA E IGG) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 554R2019 SSA and manufactured by BIO-RAD, S.A.. The device was registered on March 15, 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
554R2019 SSA
AUTOINMUNE EIA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODIES (ASCA) IGA E IGG
COFEPRIS Analysis ID: 554R2019 SSA
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Product Use / Uso del Producto
Spanish

EL BIO-RAD AUTOIMMUNE EIA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODIES (ASCA) IGA E IGG TEST ES UN ENZIMOINMUNOANรLISIS EN FASE Sร“LIDA (ELISA) QUE EMPLEA MANANO PURIFICADO PARA LA DETECCIร“N SEMICUANTITATIVA Y CUALITATIVA DE ANTICUERPOS IGA E IGG ANTI-SACCHARO

English

THE BIO-RAD AUTOIMMUNE EIA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODIES (ASCA) IGA AND IGG TEST IS A SOLID PHASE ENZYME IMMUNOASSAY (ELISA) THAT USES PURIFIED MANNAN FOR THE SEMI-QUANTITATIVE AND QUALITATIVE DETECTION OF IGA AND IGG ANTI-SACCHARO ANTIBODIES

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
III. AGENTES DE DIAGNร“STICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
INMUNOENSAYO PARA LA DETERMINACIร“N DE IGA E IGG ASCA.
Trade Name (English)
IMMUNOASSAY FOR THE DETERMINATION OF IGA AND IGG ASCA.
Registration Information
Analysis ID
554R2019 SSA
Registration Date
March 15, 2019
Manufacturer / Fabricante
Name (Spanish)
BIO-RAD, S.A.
Name (English)
BIO-RAD, S.A.