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DAT IGG-DILUTION - COFEPRIS Registration 1139R2018 SSA

Access comprehensive regulatory information for DAT IGG-DILUTION (DAT IGG-DILUTION) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1139R2018 SSA and manufactured by BIO-RAD, S.A.. The device was registered on May 17, 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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COFEPRIS Official Data
Clase I
1139R2018 SSA
DAT IGG-DILUTION
COFEPRIS Analysis ID: 1139R2018 SSA
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Product Use / Uso del Producto
Spanish

DETERMINACIร“N DE IGG. LA TARJETA ID-CARD โ€œDAT IGG-DILUTIONโ€ PROPORCIONA UNA INDICACIร“N DE LA SIGNIFICACIร“N CLรNICA DE UNA PRUEBA DE ANTIGLOBULINA DIRECTA POSITIVA. AGENTES DE DIAGNร“STICO. PARA USO EXCLUSIVO EN LABORATORIOS CLรNICOS O DE GABINETE.

English

DETERMINATION OF IGG. THE ID-CARD "DAT IGG-DILUTION" PROVIDES AN INDICATION OF THE CLINICAL SIGNIFICANCE OF A POSITIVE DIRECT ANTIGLOBULIN TEST. DIAGNOSTIC AGENTS. FOR USE IN CLINICAL OR CABINET LABORATORIES ONLY.

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)
ANTICUERPOS ANTI-IGG (DE CONEJO)
Trade Name (English)
ANTI-IGG ANTIBODIES (RABBIT)
Registration Information
Analysis ID
1139R2018 SSA
Registration Date
May 17, 2018
Manufacturer / Fabricante
Name (Spanish)
BIO-RAD, S.A.
Name (English)
BIO-RAD, S.A.