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SIMPLEXA™ HSV 1 & 2 DIRECT AND POSITIVE CONTROL PACK - COFEPRIS Registration 220R2019 SSA

Access comprehensive regulatory information for SIMPLEXA™ HSV 1 & 2 DIRECT AND POSITIVE CONTROL PACK (SIMPLEXA™ HSV 1 & 2 DIRECT AND POSITIVE CONTROL PACK) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 220R2019 SSA and manufactured by DIASORIN MÉXICO, S.A. DE C.V.. The device was registered on February 07, 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 II
220R2019 SSA
SIMPLEXA™ HSV 1 & 2 DIRECT AND POSITIVE CONTROL PACK
COFEPRIS Analysis ID: 220R2019 SSA
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Product Use / Uso del Producto
Spanish

EL ENSAYO DIASORIN MOLECULAR SIMPLEXA™ HSV 1 & 2 DIRECT ESTÁ DESTINADO A USARSE CON EL INSTRUMENTO LIASION® MDX PARA LA DETECCIÓN CUALITATIVA Y LA DIFERENCIACIÓN DEL VHS-1 (HSV-1) Y VHS-2 (HSV-2) PRESENTES EN EL LÍQUIDO CEFALORRAQUÍDEO (LCR) O EN TORUNDAS

English

THE DIASORIN MOLECULAR SIMPLEXA™ HSV 1 & 2 DIRECT ASSAY IS INTENDED FOR USE WITH THE LIASION® MDX INSTRUMENT FOR THE QUALITATIVE DETECTION AND DIFFERENTIATION OF HSV-1 (HSV-1) AND HSV-2 (HSV-2) PRESENT IN CEREBROSPINAL FLUID (CSF) OR SWABS

Device Classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
III. AGENTES DE DIAGNÓSTICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
ENSAYO MOLECULAR PARA DETERMINACIÓN DEL ADN VIRAL DEL HERPES SIMPLE, VHS-1 Y VHS-2
Trade Name (English)
MOLECULAR ASSAY FOR DETERMINATION OF HERPES SIMPLEX VIRAL DNA, HSV-1 AND HSV-2
Registration Information
Analysis ID
220R2019 SSA
Registration Date
February 07, 2019
Manufacturer / Fabricante
Name (English)
DIASORIN MÉXICO, S.A. DE C.V.