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HYDRAGEL BENCE JONES. - COFEPRIS Registration 1641R2020 SSA

Access comprehensive regulatory information for HYDRAGEL BENCE JONES. (HYDRAGEL, I THINK, IS JONES.) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1641R2020 SSA and manufactured by LABORATORIOS LICON, S.A.. The device was registered on December 11, 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 I
1641R2020 SSA
HYDRAGEL BENCE JONES.
COFEPRIS Analysis ID: 1641R2020 SSA
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Product Use / Uso del Producto
Spanish

LOSKITSHYDRAGEL1BENCEJONES,2BENCEJONES,4BENCEJONESY9BENCEJONESESTÁNDISEÑADOS PARA LA DETECCIÓN DEPROTEÍNASBENCEJONES,OCADENASLIGERASLIBRES(KAPPAOLAMBDA)ENORINAOSUEROHUMANO, RESPECTIVAMENTE, MEDIANTEINMUNOFIJACIÓN EN GELES DE AGAROSATAMPONADOS ALCALINAMENTE (PH 9.2). SONUTILIZADOS JUNTO CON EL SISTEMASEMIAUTOMATICO HYDRASYS, REALIZANDOSEASÍTODOELCONJUNTODEPASOSNECESARIOSPARALAOBTENCIÓNDEGELESLISTOSPARASUPOSTERIOR INTERPRETACIÓN.

English

THE KITSHYDRAGEL1BENCEJONES,2BENCEJONES,4BENCEJONESand 9BENCEJONES ARE DESIGNED FOR THE DETECTION OF PROTEINSBENCEJONES,OCADENASLIGERASLIBRES(KAPPAOLAMBDA)ENURINEOR HUMAN SERUM, RESPECTIVELY, BY IMMUNOFIXATION IN ALKALINE AGAROSATE GELS (PH 9.2). THEY ARE USED TOGETHER WITH THE HYDRASYS SEMI-AUTOMATIC SYSTEM, THUS CARRYING OUT ALL THE SET OF STEPS NECESSARY TO OBTAIN READY GELS FOR SUBSEQUENT INTERPRETATION.

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)
REACTIVODEDIAGNÓSTICOINVITROPARA INMUNOGLOBULINAS CONCADENA LIGERA KAPPA O LAMBDA.
Trade Name (English)
DIAGNOSTIC REAGENTINVITRO FOR IMMUNOGLOBULINS WITH KAPPA OR LAMBDA LIGHT CHAIN.
Registration Information
Analysis ID
1641R2020 SSA
Registration Date
December 11, 2020
Manufacturer / Fabricante
Name (English)
LABORATORIOS LICON, S.A.