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FASTPACK® TESTOSTERONE. - COFEPRIS Registration 31R2019 SSA

Access comprehensive regulatory information for FASTPACK® TESTOSTERONE. (FASTPACK® TESTOSTERONE.) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 31R2019 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
31R2019 SSA
FASTPACK® TESTOSTERONE.
COFEPRIS Analysis ID: 31R2019 SSA
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Product Use / Uso del Producto
Spanish

EL FASTPACK® TESTOSTERONE ESTÁ DISEÑADA PARA SU USO CON EL SISTEMA FASTPACK® ANALYZER. ES UN INMUNOENSAYO IN VITRO BASADO EN PARTÍCULAS PARAMAGNÉTICAS PARA LA DETECCIÓN CUANTITATIVA DE TESTOSTERONA TOTAL EN EL SUERO Y PLASMA HUMANO. ESTE MÉTODO DE DETECCI

English

THE FASTPACK TESTOSTERONE IS DESIGNED FOR USE WITH THE FASTPACK®® ANALYZER SYSTEM. IT IS AN IN VITRO IMMUNOASSAY BASED ON PARAMAGNETIC PARTICLES FOR THE QUANTITATIVE DETECTION OF TOTAL TESTOSTERONE IN HUMAN SERUM AND PLASMA. THIS METHOD OF DETECTION

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)
INMUNOENSAYO QUIMIOLUMINISCENTE PARA DETERMINACIÓN DE TESTOSTERONA
Trade Name (English)
CHEMOLUMINESCENT IMMUNOASSAY FOR TESTOSTERONE DETERMINATION
Registration Information
Analysis ID
31R2019 SSA
Registration Date
January 16, 2019
Manufacturer / Fabricante
Name (English)
KABLA COMERCIAL, S.A. DE C.V.