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CALIBRATOR Β2-MICROGLOBULIN. - COFEPRIS Registration 1454R2021 SSA

Access comprehensive regulatory information for CALIBRATOR Β2-MICROGLOBULIN. (CALIBRATOR Β2-MICROGLOBULIN.) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1454R2021 SSA and manufactured by PRODUCTOS ROCHE,S.A. DE C.V.. The device was registered on September 21, 2021.

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
1454R2021 SSA
CALIBRATOR Β2-MICROGLOBULIN.
COFEPRIS Analysis ID: 1454R2021 SSA
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Product Use / Uso del Producto
Spanish

CALIBRATOR Β2-MICROGLOBULIN ESTÁDESTINADO A LA CALIBRACIÓN DE LOSMÉTODOS CUANTITATIVOS DE ROCHE ENANALIZADORESROCHEDEQUÍMICACLÍNICA.AGENTE DE DIAGNÓSTICO PARA USO INVITRO. PARA USO EXCLUSIVO ENLABORATORIOS CLÍNICOS O DE GABINETES.

English

CALIBRATOR Β2-MICROGLOBULIN IS INTENDED FOR THE CALIBRATION OF ROCHE'S QUANTITATIVE METHODS IN CLINICAL CHEMISTRY ROCHE ANALYZERS. DIAGNOSTIC AGENT FOR INVITRO USE. FOR USE ONLY IN CLINICAL LABORATORIES OR CABINETS.

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)
CALIBRADOR.
Trade Name (English)
CALIBRADOR.
Registration Information
Analysis ID
1454R2021 SSA
Registration Date
September 21, 2021
Manufacturer / Fabricante
Name (English)
PRODUCTOS ROCHE,S.A. DE C.V.