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QUANTASE™ NEONATAL BIOTINIDASE DEFICIENCY SCREENING (BLOOD SPOT CONTROLS). - COFEPRIS Registration 1435R2018 SSA

Access comprehensive regulatory information for QUANTASE™ NEONATAL BIOTINIDASE DEFICIENCY SCREENING (BLOOD SPOT CONTROLS). (QUANTASE™ NEONATAL BIOTINIDASE DEFICIENCY SCREENING (BLOOD SPOT CONTROLS).) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1435R2018 SSA and manufactured by BIO-RAD, S.A.. The device was registered on June 07, 2018.

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
1435R2018 SSA
QUANTASE™ NEONATAL BIOTINIDASE DEFICIENCY SCREENING (BLOOD SPOT CONTROLS).
COFEPRIS Analysis ID: 1435R2018 SSA
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Product Use / Uso del Producto
Spanish

LOS CONTROLES DE MANCHA DE SANGRE SE EMPLEAN COMO REFERENCIA DE DESEMPEÑO E IMITAN LAS CONDICIONES DE UNA MUESTRA PARA EVALUAR EN PROCESO EN CONJUNTO CON EL KIT QUANTASETM NEONATAL BIOTINIDASE DEFICIENCY SCREENING. AGENTES DE DIAGNÓSTICO. PARA USO EXCLUS

English

BLOOD STAIN CONTROLS ARE USED AS A PERFORMANCE BENCHMARK AND MIMIC THE CONDITIONS OF A SAMPLE TO BE EVALUATED IN PROCESS IN CONJUNCTION WITH THE QUANTASETM NEONATAL BIOTINIDASE DEFICIENCY SCREENING KIT. DIAGNOSTIC AGENTS. FOR EXCLUSIVE USE

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
III. AGENTES DE DIAGNÓSTICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
CONTROLES DE MANCHA DE SANGRE.
Trade Name (English)
BLOOD STAIN CONTROLS.
Registration Information
Analysis ID
1435R2018 SSA
Registration Date
June 07, 2018
Manufacturer / Fabricante
Name (Spanish)
BIO-RAD, S.A.
Name (English)
BIO-RAD, S.A.