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VYSIS ALK BREAK APART FISH PROBE KIT - COFEPRIS Registration 1801R2019 SSA

Access comprehensive regulatory information for VYSIS ALK BREAK APART FISH PROBE KIT (VYSIS ALK BREAK APART FISH PROBE 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 1801R2019 SSA and manufactured by ABBOTT LABORATORIES DE Mร‰XICO, S.A. DE C.V.. The device was registered on September 02, 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 I
1801R2019 SSA
VYSIS ALK BREAK APART FISH PROBE KIT
COFEPRIS Analysis ID: 1801R2019 SSA
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Product Use / Uso del Producto
Spanish

PARA DETECTAR REORDENAMIENTOS EN EL GEN ALK A TRAVร‰S DE LA HIBRIDACIร“N IN SITU POR FLUORESCENCIA (FISH) EN MUESTRAS DE TEJIDO DE CARCINOMA DE PULMร“N NO MICROCรTICO (NSCLC, POR SUS SIGLAS EN INGLร‰S) FIJADAS CON FORMOL Y EMBEBIDAS EN PARAFINA (FFPE) PARA AY

English

TO DETECT REARRANGEMENTS IN THE ALK GENE THROUGH FLUORESCENCE IN SITU HYBRIDIZATION (FISH) IN FORMALIN-FIXED, PARAFFIN-EMBEDDED (FFPE) NON-SMALL CELL LUNG CARCINOMA (NSCLC) TISSUE SAMPLES FOR AY

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
III. AGENTES DE DIAGNร“STICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
ENSAYO PARA DETECTAR REORDENAMIENTO EN EL GEN ALK
Trade Name (English)
ASSAY TO DETECT REARRANGEMENT IN THE ALK GENE
Registration Information
Analysis ID
1801R2019 SSA
Registration Date
September 02, 2019
Manufacturer / Fabricante
Name (English)
ABBOTT LABORATORIES DE Mร‰XICO, S.A. DE C.V.