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PROTEIN C CHROM - COFEPRIS Registration 531R2022 SSA

Access comprehensive regulatory information for PROTEIN C CHROM (PROTEIN C CHROMIUM) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 531R2022 SSA and manufactured by PRODUCTOSROCHE, S.A. DE C.V.. The device was registered on June 24, 2022.

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
531R2022 SSA
PROTEIN C CHROM
COFEPRIS Analysis ID: 531R2022 SSA
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Product Use / Uso del Producto
Spanish

PRUEBA CROMOGÉNICA PARA LA DETERMINACIÓNCUANTITATIVA DE LA ACTIVIDAD DE LA PROTEÍNA C ENPLASMACITRATADOENLOSANALIZADORESROCHECOBAST.ESTA PRUEBA ESTÁ CONCEBIDA COMO AYUDA EN ELDIAGNÓSTICO DE LA DEFICIENCIA HEREDITARIA YADQUIRIDA DE LA PROTEÍNA C,QUE INTERVIENE EN ELPROCESO ANTICOAGULACIÓN AGENTE DE DIAGNÓSTICOPARA USO IN VITRO. PARA USO EXCLUSIVO ENLABORATORIOS CLÍNICOS O DE GABINETE.

English

CHROMOGENIC TEST FOR THE QUANTITATIVE DETERMINATION OF THE ACTIVITY OF PROTEIN C IN PLASMACTREATED IN THE ROCHECOBAST ANALYZERS. THIS TEST IS DESIGNED TO AID IN THE DIAGNOSIS OF HEREDITARY AND ACQUIRED DEFICIENCY OF PROTEIN C, WHICH IS INVOLVED IN THE ANTICOAGULATION PROCESS. FOR USE ONLY IN CLINICAL OR CABINET LABORATORIES.

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)
PRUEBACROMOGÉNICAPARALA DETERM
Trade Name (English)
CHROMOGENIC TEST for DETERM
Registration Information
Analysis ID
531R2022 SSA
Registration Date
June 24, 2022
Manufacturer / Fabricante
Name (English)
PRODUCTOSROCHE, S.A. DE C.V.