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PARATHYROID HORMONE (CLIA) WIENER LAB. - COFEPRIS Registration 1835R2019 SSA

Access comprehensive regulatory information for PARATHYROID HORMONE (CLIA) WIENER LAB. (PARATHYROID HORMONE (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 1835R2019 SSA and manufactured by REPRESENTACIONES LABIN MÉXICO, S.A. DE C.V.. The device was registered on September 10, 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
1835R2019 SSA
PARATHYROID HORMONE (CLIA) WIENER LAB.
COFEPRIS Analysis ID: 1835R2019 SSA
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Product Use / Uso del Producto
Spanish

INMUNOENSAYO QUIMIOLUMINISCENTE (CLIA) PARA LA DETERMINACIÓN CUANTITATIVA DE HORMONA PARATIROIDEA (PTH) EN SUERO O PLASMA. AGENTE DE DIAGNÓSTICO PARA USO IN VITRO. PARA USO EXCLUSIVO EN LABORATORIOS CLÍNICOS O DE GABINETE.

English

CHEMOLUMINESCENT IMMUNOASSAY (CLIA) FOR THE QUANTITATIVE DETERMINATION OF PARATHYROID HORMONE (PTH) IN SERUM OR PLASMA. DIAGNOSTIC AGENT FOR IN VITRO USE. FOR USE IN CLINICAL OR CABINET LABORATORIES 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)
REACTIVO PARA LA DETERMINACIÓN DE LA HORMONA PARATIROIDEA (PTH).
Trade Name (English)
REAGENT FOR THE DETERMINATION OF PARATHYROID HORMONE (PTH).
Registration Information
Analysis ID
1835R2019 SSA
Registration Date
September 10, 2019
Manufacturer / Fabricante
Name (English)
REPRESENTACIONES LABIN MÉXICO, S.A. DE C.V.