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FASTPACK® FT4 - COFEPRIS Registration 390R2019 SSA

Access comprehensive regulatory information for FASTPACK® FT4 (FASTPACK® FT4) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 390R2019 SSA and manufactured by KABLA COMERCIAL, S.A. DEC.V.. The device was registered on February 27, 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
390R2019 SSA
FASTPACK® FT4
COFEPRIS Analysis ID: 390R2019 SSA
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Product Use / Uso del Producto
Spanish

EL DISPOSITIVO FASTPACK® FT4 ES UN INMUNOENSAYO DE QUIMIOLUMINISCENCIA DE PARTÍCULAS PARAMAGNÉTICAS PARA LA DETERMINACIÓN CUANTITATIVA IN VITRO DE TIROXINA LIBRE (FT4) EN SUERO HUMANO. EL INMUNOENSAYO DE T4 LIBRE FASTPACK® ESTÁ DISEÑADO PARA SER UTILIZADO

English

THE FASTPACK® FT4 DEVICE IS A PARAMAGNETIC PARTICLE CHEMILUMINESCENCE IMMUNOASSAY FOR THE IN VITRO QUANTITATIVE DETERMINATION OF FREE THYROXINE (FT4) IN HUMAN SERUM. FASTPACK FREE T4 IMMUNOASSAY® IS DESIGNED TO BE USED

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)
ENSAYO PARA LA DETERMINACIÓN DE TIROXINA LIBRE (FT4)
Trade Name (English)
TEST FOR THE DETERMINATION OF FREE THYROXINE (FT4)
Registration Information
Analysis ID
390R2019 SSA
Registration Date
February 27, 2019
Manufacturer / Fabricante
Name (English)
KABBALAH COMMERCIAL, S.A. DEC.V.