Mexico COFEPRIS registration 1783R2019 SSA

ESTRIOL (CLIA) WIENER LAB.

EN: ESTRIOL (CLIA) WIENER LAB.
Mexico flagMexico·Clase I·III. DIAGNOSTIC AGENTS·REPRESENTACIONES LABIN MÉXICO, S.A. DE C.V.·Registered August 30, 2019
Product Use / Uso del Producto
Spanish

INMUNOENSAYO QUIMIOLUMINISCENTE PARA LA DETERMINACIÓN CUANTITATIVA DE ESTRIOL (E3) EN SUERO. PARA USO DE DIAGNÓSTICO IN VITRO. AGENTE DE DIAGNÓSTICO PARA USO EXCLUSIVO DE LABORATORIO CLÍNICO O DE GABINETE.

English

CHEMOLUMINESCENT IMMUNOASSAY FOR THE QUANTITATIVE DETERMINATION OF SERUM ESTRIOL (E3). FOR IN VITRO DIAGNOSTIC USE. DIAGNOSTIC AGENT FOR CLINICAL LABORATORY OR CABINET USE ONLY.

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 LA DETERMINACIÓN CUANTITATIVA DE ESTRIOL (E3) EN SUERO.
Trade Name (English)
CHEMOLUMINESCENT IMMUNOASSAY FOR THE QUANTITATIVE DETERMINATION OF SERUM ESTRIOL (E3).
Registration information
Analysis ID
1783R2019 SSA
Registration Date
August 30, 2019
Manufacturer / Fabricante
Name (English)
REPRESENTACIONES LABIN MÉXICO, S.A. DE C.V.
About this record

Access comprehensive regulatory information for ESTRIOL (CLIA) WIENER LAB. (ESTRIOL (CLIA) WIENER LAB.) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1783R2019 SSA and manufactured by REPRESENTACIONES LABIN MÉXICO, S.A. DE C.V.. The device was registered on August 30, 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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