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FASTPACK® SYSTEM CONTROL KIT. - COFEPRIS Registration 32R2019 SSA

Access comprehensive regulatory information for FASTPACK® SYSTEM CONTROL KIT. (FASTPACK® SYSTEM CONTROL 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 32R2019 SSA and manufactured by KABLA COMERCIAL, S.A. DE C.V.. The device was registered on January 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 I
32R2019 SSA
FASTPACK® SYSTEM CONTROL KIT.
COFEPRIS Analysis ID: 32R2019 SSA
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Product Use / Uso del Producto
Spanish

FASTPACK® SYSTEM CONTROL KIT ES UN CONTROL DE CALIDAD PROBADO PARA LA VERIFICACIÓN DE LA EXACTITUD Y PRECISIÓN DEL FASTPACK® ANALYZER CUANDO SE UTILIZA PARA LA DETERMINACIÓN CUANTITATIVA DE LOS ANALITOS TSH (HORMONA ESTIMULANTE DE LA TIROIDES), T4 LIBRE

English

FASTPACK SYSTEM CONTROL KIT IS A QUALITY CONTROL TESTED FOR VERIFICATION OF THE ACCURACY AND PRECISION OF THE FASTPACK®® ANALYZER WHEN USED FOR THE QUANTITATIVE DETERMINATION OF TSH (THYROID STIMULATING HORMONE), FREE T4 ANALYTES

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)
REACTIVO CONTROL.
Trade Name (English)
REACTIVE CONTROL.
Registration Information
Analysis ID
32R2019 SSA
Registration Date
January 16, 2019
Manufacturer / Fabricante
Name (English)
KABLA COMERCIAL, S.A. DE C.V.