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SISTEMA CFX 96™ DX - COFEPRIS Registration 899E2021 SSA

Access comprehensive regulatory information for SISTEMA CFX 96™ DX (SISTEMA CFX 96™ DX) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 899E2021 SSA and manufactured by BIO-RAD, S.A.. The device was registered on May 26, 2021.

This page provides complete registration details including product type (I. MEDICAL EQUIPMENT), 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
899E2021 SSA
SISTEMA CFX 96™ DX
COFEPRIS Analysis ID: 899E2021 SSA
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Product Use / Uso del Producto
Spanish

LOS SISTEMAS CFX96™ DX Y CFX96™ DEEPWELLDXESTÁNPREVISTOSPARAREALIZARPCR BASADO EN FLUORESCENCIA PARADETECTAR Y CUANTIFICAR SECUENCIAS DEÁCIDO NUCLEICO, Y PARA USARSE COMOHERRAMIENTAS DE DIAGNÓSTICO IN VITROPORPARTEDETÉCNICOSDELABORATORIOCUALIFICADOS.

English

THE CFX96 DX AND CFX96™™ DEEPWELLD SYSTEMS ARE INTENDED TO PERFORM FLUORESCENCE-BASED PCR TO DETECT AND QUANTIFY NUCLEIC ACID SEQUENCES, AND TO BE USED AS IN VITRO DIAGNOSTIC TOOLS BY QUALIFIED LABORATORY TECHNICIANS.

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
I. EQUIPO MÉDICO
Product Type (English)
I. MEDICAL EQUIPMENT
Trade Name (Spanish)
SISTEMAS DE AMPLIFICACIÓN MEDIANTEPCR
Trade Name (English)
AMPLIFICATION SYSTEMS BY PCR
Registration Information
Analysis ID
899E2021 SSA
Registration Date
May 26, 2021
Manufacturer / Fabricante
Name (Spanish)
BIO-RAD, S.A.
Name (English)
BIO-RAD, S.A.