Mexico COFEPRIS registration 1344R2019 SSA

VENTANA MSLN (SP74) DX ASSAY

EN: VENTANA MSLN (SP74) DX ASSAY
Mexico flagMexico·Clase II·III. DIAGNOSTIC AGENTS·PRODUCTOS ROCHE, S.A. DE C.V.·Registered July 16, 2019
Product Use / Uso del Producto
Spanish

VENTANA MSLN (SP74) DX ASSAY SE HA DISEÑADO PARA LA EVALUACIÓN INMUNOHISTOQUÍMICA DE LA PROTEÍNA MESOTELINA EN TEJIDO (FFPE) FIJADO CON FORMOL Y EMBEBIDOS EN PARAFINA. ESTE PRODUCTO DEBE SER INTERPRETADO POR UN ANATOMOPATÓLOGO CUALIFICADO EN CONJUNCIÓN

English

MSLN WINDOW (SP74) DX ASSAY IS DESIGNED FOR THE IMMUNOHISTOCHEMICAL EVALUATION OF FORMALIN-FIXED, PARAFFIN-EMBEDDED TISSUE MESOTHELIN PROTEIN (FFPE). THIS PRODUCT SHOULD BE INTERPRETED BY A QUALIFIED PATHOLOGIST IN CONJUNCTION

Device classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
III. AGENTES DE DIAGNÓSTICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
ANTICUERPO MONOCLONAL
Trade Name (English)
MONOCLONAL ANTIBODY
Registration information
Analysis ID
1344R2019 SSA
Registration Date
July 16, 2019
Manufacturer / Fabricante
Name (English)
PRODUCTOS ROCHE, S.A. DE C.V.
About this record

Access comprehensive regulatory information for VENTANA MSLN (SP74) DX ASSAY (VENTANA MSLN (SP74) DX ASSAY) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 1344R2019 SSA and manufactured by PRODUCTOS ROCHE, S.A. DE C.V.. The device was registered on July 16, 2019.

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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