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ELECSYS IGFBP-3 - COFEPRIS Registration 2125R2021 SSA

Access comprehensive regulatory information for ELECSYS IGFBP-3 (ELECSYS IGFBP-3) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 2125R2021 SSA and manufactured by PRODUCTOS ROCHE,S.A. DE C.V.. The device was registered on December 14, 2021.

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
2125R2021 SSA
ELECSYS IGFBP-3
COFEPRIS Analysis ID: 2125R2021 SSA
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Product Use / Uso del Producto
Spanish

PRUEBAINMUNOLÓGICA IN VITRO PARALADETERMINACIÓN CUANTITATIVA DE LAPROTEÍNA DE UNIÓN AL FACTOR DECRECIMIENTO INSULÍNICO TIPO 3(IGFBP‑3,PORSUSSIGLASENINGLÉS)EN SUERO Y PLASMA HUMANOS. LADETERMINACIÓN DE IGFBP‑3CONSTITUYEUNAAYUDAENLAEVALUACIÓNDE TRASTORNOS DE CRECIMIENTOCONJUNTAMENTE CON OTROS EXÁMENESCLÍNICOS Y DE LABORATORIO.

English

IN VITRO IMMUNOLOGICAL TEST FOR THE QUANTITATIVE DETERMINATION OF INSULIN-LIKE GROWTH FACTOR-BINDING PROTEIN 3 (IGFBP-3) IN HUMAN SERUM AND PLASMA. THE DETERMINATION OF IGFBP-3 IS AN AID IN THE ASSESSMENT OF GROWTH DISORDERS IN CONJUNCTION WITH OTHER CLINICAL AND LABORATORY EXAMINATIONS.

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)
PRUEBA PARA DETERMINACIÓN DE LAPROTEÍNA IGFBP-3
Trade Name (English)
TEST FOR DETERMINATION OF IGFBP-3 PROTEIN
Registration Information
Analysis ID
2125R2021 SSA
Registration Date
December 14, 2021
Manufacturer / Fabricante
Name (English)
PRODUCTOS ROCHE,S.A. DE C.V.