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LIAISON® BIOTRIN PARVOVIRUS B19 IGG - COFEPRIS Registration 1584R2018 SSA

Access comprehensive regulatory information for LIAISON® BIOTRIN PARVOVIRUS B19 IGG (LIAISON® BIOTRIN PARVOVIRUS B19 IGG) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 1584R2018 SSA and manufactured by DIASORIN MÉXICO, S.A. DE C.V.. The device was registered on June 19, 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 II
1584R2018 SSA
LIAISON® BIOTRIN PARVOVIRUS B19 IGG
COFEPRIS Analysis ID: 1584R2018 SSA
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Product Use / Uso del Producto
Spanish

EL ENSAYO LIAISON® BIOTRIN PARVOVIRUS B19 IGG EMPLEA LA TECNOLOGÍA DE LA QUIMIOLUMINISCENCIA (CLIA) EN UN ENSAYO INMUNOLÓGICO PARA LA DETERMINACIÓN CUALITATIVA DE ANTICUERPOS IGG ANTI-PARVOVIRUS B19 EN MUESTRAS DE SUERO O PLASMA HUMANO. EL ENSAYO DEBE REA

English

THE LIAISON® BIOTRIN PARVOVIRUS B19 IGG ASSAY EMPLOYS CHEMILUMINESCENCE TECHNOLOGY (CLIA) IN AN IMMUNOLOGICAL ASSAY FOR THE QUALITATIVE DETERMINATION OF ANTI-PARVOVIRUS B19 IGG ANTIBODIES IN HUMAN SERUM OR PLASMA SAMPLES. THE TEST MUST BE REA

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)
KIT PARA LA DETERMINACIÓN DE ANTICUERPOS IGG ANTI-PARVOVIRUS B19
Trade Name (English)
KIT FOR THE DETERMINATION OF IGG ANTIBODIES ANTI-PARVOVIRUS B19
Registration Information
Analysis ID
1584R2018 SSA
Registration Date
June 19, 2018
Manufacturer / Fabricante
Name (English)
DIASORIN MÉXICO, S.A. DE C.V.