Pure Global

HYDRAGEL ISO-CK - COFEPRIS Registration 324R2020 SSA

Access comprehensive regulatory information for HYDRAGEL ISO-CK (HYDRAGEL ISO-CK) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 324R2020 SSA and manufactured by LABORATORIOS LICON, S.A.. The device was registered on March 17, 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.

Free Database
Powered by Pure Global AI
COFEPRIS Official Data
Clase I
324R2020 SSA
HYDRAGEL ISO-CK
COFEPRIS Analysis ID: 324R2020 SSA
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Use / Uso del Producto
Spanish

LOS KITS HYDRAGEL 7, 15 Y 30 ISO-CK ESTÁNDISEÑADOS PARA LA IDENTIFICACIÓN YCUANTIFICACIÓNDELOSTRESISOENZIMASDELACREATINAKINASA(CK)ENSUEROHUMANOMEDIANTE ELECTROFORESIS EN GELES DEAGAROSA TAMPONADOS ALCALINOS (PH 8.4).LOS KITS SE UTILIZAN CON EL SISTEMA DEELECTROFORESISSEMIAUTOMÁTICOHYDRASYS.LOSGELESRESULTANTESESTÁN LISTOSPARAUN EXAMEN VISUAL Y PARA SU LECTURADENSITOMÉTRICA PARA OBTENER UNACUANTIFICACIÓN DE LAS FRACCIONESINDIVIDUALES.

English

THE HYDRAGEL 7, 15 AND 30 ISO-CK KITS ARE DESIGNED FOR THE IDENTIFICATION AND QUANTIFICATION OF LOSTRESISOENZIMASDELACREATINAKINASA(CK)ENSUEROHUMANO BY ELECTROPHORESIS IN ALKALINE BUFFERED DEAGAROSE GELS (PH 8.4). THE KITS ARE USED WITH THE HYDRASYS SEMIAUTOMATIC ELECTROPHORESIS SYSTEM. THE RESULTING GELS ARE READY FOR VISUAL EXAMINATION AND DENSITOMETRIC READING TO QUANTIFY INDIVIDUAL FRACTIONS.

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)
REACTIVOS PARA LADETERMINACIÓNDEISOENZIMASDELA CREATINA KINASA (CK).
Trade Name (English)
REAGENTS FOR THE DETERMINATION OF ISOENZIMASDELA CREATINE KINASE (CK).
Registration Information
Analysis ID
324R2020 SSA
Registration Date
March 17, 2020
Manufacturer / Fabricante
Name (English)
LABORATORIOS LICON, S.A.