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AESKULISA® PHOSPHOLIPID-SCREEN. - COFEPRIS Registration 1419R2019 SSA

Access comprehensive regulatory information for AESKULISA® PHOSPHOLIPID-SCREEN. (AESKULISA® PHOSPHOLIPID-SCREEN.) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1419R2019 SSA and manufactured by GRIFOLS MÉXICO, S.A. DE C.V.. The device was registered on July 22, 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
1419R2019 SSA
AESKULISA® PHOSPHOLIPID-SCREEN.
COFEPRIS Analysis ID: 1419R2019 SSA
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Product Use / Uso del Producto
Spanish

AESKULISA® PHOSPHOLIPID-SCREEN ES UN ENZIMOINMUNOENSAYO EN FASE SÓLIDA PARA LA DETECCIÓN COMBINADA CUALITATIVA DE ANTICUERPOS IGG E IGM CONTRA FOSFOLÍPIDOS EN SUERO HUMANO. CADA POCILLO ESTÁ RECUBIERTO CON Β2-GLICOPROTEÍNA I HUMANA, CARDIOLIPINA Y F

English

AESKULISA® PHOSPHOLIPID-SCREEN IS A SOLID-PHASE ENZYME IMMUNOASSAY FOR THE QUALITATIVE COMBINED DETECTION OF IGG AND IGM ANTIBODIES AGAINST PHOSPHOLIPIDS IN HUMAN SERUM. EACH WELL IS COATED WITH HUMAN Β2-GLYCOPROTEIN I, CARDIOLIPIN AND F

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)
KIT DE INMUNOANÁLISIS LIGADO A ENZIMAS (ELISA) PARA LA DETECCIÓN CUALITATIVA COMBINADA DE ANTICUERPO
Trade Name (English)
ENZYME-LINKED IMMUNOASSAY KIT (ELISA) FOR COMBINED QUALITATIVE ANTIBODY DETECTION
Registration Information
Analysis ID
1419R2019 SSA
Registration Date
July 22, 2019
Manufacturer / Fabricante
Name (English)
GRIFOLS MÉXICO, S.A. DE C.V.