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HYDRAGEL IF. - COFEPRIS Registration 1541R2020 SSA

Access comprehensive regulatory information for HYDRAGEL IF. (HYDRAGEL IF.) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 1541R2020 SSA and manufactured by LABORATORIOS LICON, S.A.. The device was registered on November 23, 2020.

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
1541R2020 SSA
HYDRAGEL IF.
COFEPRIS Analysis ID: 1541R2020 SSA
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Product Use / Uso del Producto
Spanish

LOS KITS HYDRAGEL 1 IF, 2 IF, 4 IF Y 9 IFPERMITEN LA DETECCIÓN DE PROTEÍNASMONOCLONALES EN EL SUERO Y LA ORINAHUMANOS,MEDIANTEINMUNOFIJACIÓNENGELDEAGAROSAENELSISTEMASEMIAUTOMÁTICOHYDRASYS. LAS PROTEÍNAS, SEPARADASMEDIANTE ELECTROFORESIS EN GELES DEAGAROSA TAMPONADOS ALCALINOS (PH 9.2),SON INCUBADAS CON ANTISUEROSINDIVIDUALESQUESONESPECÍFICOSPARALASCADENASPESADASGAMMA(IGG),ALFA(IGA)YMU (IG M), Y PARA LAS CADENAS LIGERASKAPPA (LIBRE Y UNIDA) Y LAMBDA (LIBRE Y UNI

English

THE HYDRAGEL 1 IF, 2 IF, 4 IF AND 9 IF KITS ALLOW THE DETECTION OF MONOCLONAL PROTEINS IN HUMAN SERUM AND URINE, BY IMMUNOFIXATION IN GELDEAGAROSA, IN THE SEMIAUTOMATIC HYDRASYS SYSTEM. THE PROTEINS, SEPARATED BY ELECTROPHORESIS INTO ALKALINE BUFFERED AAGAROSE GELS (PH 9.2), ARE INCUBATED WITH INDIVIDUAL ANTISERA THAT ARE SPECIFIC FOR THE HEAVY CHAINS GAMMA(IGG),ALPHA(IGA)AND MU (IG M), AND FOR THE LIGHT CHAINS SKAPPA (FREE AND BOUND) AND LAMBDA (FREE AND UNI

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)
KITSDEDIAGNÓSTICOINVITROPARAPROTEÍNAS MONOCLONALESMEDIANTE INMUNOFIJACIÓN.
Trade Name (English)
KITSDEDIAGNÓSTICOINVITROPARAPROTEÍNAS MONOCLONALESMEDIANTE INMUNOFIJACIÓN.
Registration Information
Analysis ID
1541R2020 SSA
Registration Date
November 23, 2020
Manufacturer / Fabricante
Name (English)
LABORATORIOS LICON, S.A.