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KIT ANTI-ESTREPTOLISINA O OPTILITE®. - COFEPRIS Registration 2243R2018 SSA

Access comprehensive regulatory information for KIT ANTI-ESTREPTOLISINA O OPTILITE®. (ANTI-STREPTOLYSIN KIT O OPTILITIS®.) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 2243R2018 SSA and manufactured by INSUMOS PARA LA SALUD, S.A. DE C.V.. The device was registered on September 24, 2018.

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
2243R2018 SSA
KIT ANTI-ESTREPTOLISINA O OPTILITE®.
COFEPRIS Analysis ID: 2243R2018 SSA
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Product Use / Uso del Producto
Spanish

EL KIT ANTI-ESTREPTOLISINA O OPTILITE® TIENE COMO OBJETIVO LA CUANTIFICACIÓN IN VITRO DE LA ANTI-ESTREPTOLISINA O EN SUERO, EN EL ANALIZADOR OPTILITE® DE BINDING SITE. ESTA PRUEBA SE DEBE USAR JUNTO CON OTRAS DETERMINACIONES CLÍNICAS Y DE LABORATORIO. AG

English

THE ANTI-STREPTOLYSIN KIT OR OPTILITE AIMS AT IN VITRO QUANTIFICATION OF ANTI-STREPTOLYSIN OR IN SERUM, IN THE BINDING SITE OPTILITE®® ANALYZER. THIS TEST SHOULD BE USED IN CONJUNCTION WITH OTHER CLINICAL AND LABORATORY DETERMINATIONS. AG

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 ANTI-ESTREPTOLISINA O.
Trade Name (English)
REAGENT FOR THE DETERMINATION OF ANTI-STREPTOLYSIN O.
Registration Information
Analysis ID
2243R2018 SSA
Registration Date
September 24, 2018
Manufacturer / Fabricante
Name (English)
INSUMOS PARA LA SALUD, S.A. DE C.V.