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VENTANA SILVER ISH DNPDETECTION KIT - COFEPRIS Registration 610R2022 SSA

Access comprehensive regulatory information for VENTANA SILVER ISH DNPDETECTION KIT (VENTANA SILVER ISH DNPDETECTION KIT) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 610R2022 SSA and manufactured by PRODUCTOSROCHE, S.A. DE C.V.. The device was registered on July 13, 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
610R2022 SSA
VENTANA SILVER ISH DNPDETECTION KIT
COFEPRIS Analysis ID: 610R2022 SSA
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Product Use / Uso del Producto
Spanish

VENTANASILVERISHDNPDETECTIONKITESUNSISTEMAINDIRECTOPARADETECTARDIANASMARCADASCONDNP.ESTEKITESTÁDESTINADOALAIDENTIFICACIÓNDEDIANASPORMEDIODEHIBRIDACIÓNINSITU(ISH)CONPLATAENSECCIONESDETEJIDOFIJADASCONFORMOLEINCLUIDASEN PARAFINA SOMETIDAS A TINCIÓN EN LOSINSTRUMENTOS BENCHMARK IHC/ISH. ESTE PRODUCTODEBE SER INTERPRETADO POR UN LECTOR CUALIFICADO EN CONJUNCIÓN CON UN EXAMEN HISTOLÓGICO, LAINFORMACIÓN CLÍNICA PERTINENTE Y LOS CONTROLESADECUADOS.

English

VENTANASILVERISHDNPDETECTIONKITESAN indirect system for detecting targets tagged with dnp. THIS KIT IS INTENDED FOR TARGET IDENTIFICATION BY MEANS OF INSITU HYBRIDIZATION (ISH) WITH SILVER IN PARAFFIN-EMBEDDED EMBEDDED TISSUE SECTIONS THAT ARE STAINED ON IHC/ISH BENCHMARK INSTRUMENTS. THIS PRODUCT SHOULD BE INTERPRETED BY A QUALIFIED READER IN CONJUNCTION WITH HISTOLOGICAL EXAMINATION, RELEVANT CLINICAL INFORMATION, AND APPROPRIATE CONTROLS.

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
III. AGENTES DEDIAGNÓSTICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
SISTEMA DE DETECCIÓN DEDIANAS MARCADAS CON DNP
Trade Name (English)
DNP-MARKED TARGET DETECTION SYSTEM
Registration Information
Analysis ID
610R2022 SSA
Registration Date
July 13, 2022
Manufacturer / Fabricante
Name (English)
PRODUCTOSROCHE, S.A. DE C.V.