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VENTANA DLL3 (SP347) ASSAY - COFEPRIS Registration 1346R2019 SSA

Access comprehensive regulatory information for VENTANA DLL3 (SP347) ASSAY (VENTANA DLL3 (SP347) 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 1346R2019 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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COFEPRIS Official Data
Clase II
1346R2019 SSA
VENTANA DLL3 (SP347) ASSAY
COFEPRIS Analysis ID: 1346R2019 SSA
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Product Use / Uso del Producto
Spanish

VENTANA DLL3 (SP347) ASSAY ESTร INDICADO PARA EL USO EN LABORATORIO EN LA DETECCIร“N DE LA PROTEรNA SIMILAR A DELTA 3 (DLL3) EN CORTES DE TEJIDO FIJADO CON FORMOL Y EMBEBIDO EN PARAFINA. ESTE PRODUCTO DEBE SER INTERPRETADO POR UN ANAMOPATร“LOGO CUALIFICAD

English

VENTANA DLL3 (SP347) ASSAY IS INDICATED FOR LABORATORY USE IN THE DETECTION OF DELTA-LIKE PROTEIN 3 (DLL3) IN FORMALIN-FIXED, PARAFFIN-EMBEDDED TISSUE SECTIONS. THIS PRODUCT SHOULD BE INTERPRETED BY A QUALIFIED PATHOLOGIST

Device Classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
III. AGENTES DE DIAGNร“STICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
ANTICUERPO MONOCLONAL
Trade Name (English)
MONOCLONAL ANTIBODY
Registration Information
Analysis ID
1346R2019 SSA
Registration Date
July 16, 2019
Manufacturer / Fabricante
Name (English)
PRODUCTOS ROCHE, S.A. DE C.V.