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BRCA PLUS ONCOKITDX - COFEPRIS Registration 805R2019 SSA

Access comprehensive regulatory information for BRCA PLUS ONCOKITDX (BRCA PLUS ONCOKITDX) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 805R2019 SSA and manufactured by LABORATORIOS LICON, S.A.. The device was registered on April 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
805R2019 SSA
BRCA PLUS ONCOKITDX
COFEPRIS Analysis ID: 805R2019 SSA
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Product Use / Uso del Producto
Spanish

BRCA PLUS ONCOKITDX HA SIDO DISEร‘ADO PARA IDENTIFICAR LAS MUTACIONES PUNTUALES Y PEQUEร‘AS INSERCIONES Y DELECIONES EN LAS REGIONES CODIFICANTES, ASร COMO LOS SITIOS DE SPLICING DE LOS GENES BRCA1 Y BRCA2. ESTE KIT PERMITE DETECTAR GRANDES DELECIONES Y DU

English

BRCA PLUS ONCOKITDX HAS BEEN DESIGNED TO IDENTIFY POINT MUTATIONS AND SMALL INSERTIONS AND DELETIONS IN CODING REGIONS AS WELL AS SPLICING SITES OF BRCA1 AND BRCA2 GENES. THIS KIT ALLOWS TO DETECT LARGE DELETIONS AND DU

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)
KITS DE REACTIVOS PARA EL ANรLISIS GENร‰TICO MOLECULAR DE LOS GENES BRCA1, BRCA2 Y FARMACOGENร‰TICA AS
Trade Name (English)
REAGENT KITS FOR MOLECULAR GENETIC ANALYSIS OF BRCA1, BRCA2 AND AS PHARMACOGENETICS GENES
Registration Information
Analysis ID
805R2019 SSA
Registration Date
April 16, 2019
Manufacturer / Fabricante
Name (English)
LABORATORIOS LICON, S.A.