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Alinity i Toxo IgG Avidity Reagent Kit - SFDA Registration ME0000002987SFDAA00334

Access comprehensive regulatory information for Alinity i Toxo IgG Avidity Reagent Kit in the Saudi Arabia medical device market through Pure Global AI's free database. This Annex II List B device is registered with Saudi Arabia SFDA under registration number ME0000002987SFDAA00334 and manufactured by Abbott GmbH. & Co. KG.

This page provides complete registration details including product category (Chemicals), manufacturer information, model details, and regulatory compliance data from the official Saudi Arabia SFDA medical device database. Pure Global AI offers free access to Saudi Arabia's complete medical device registry, helping global MedTech companies navigate SFDA regulations efficiently.

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SFDA Official Data
Annex II List B
ME0000002987SFDAA00334
Alinity i Toxo IgG Avidity Reagent Kit
SFDA Registration: ME0000002987SFDAA00334
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Product Information

CMIA used for the determination of the avidity of IgG antibodies to Toxoplasma gondii

Product Use

The Alinity i Toxo IgG Avidity assay is a chemiluminescent microparticle immunoassay (CMIA) used for the determination of the avidity of IgG antibodies to Toxoplasma gondii in human serum and plasma on the Alinity i analyzer.

Device Classification
Risk Class
Annex II List B
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000002987SFDAA00334
Authorization ID
GHTF-2019-2945
Status
Active
Expire Date
May 27, 2024
Manufacturer
Manufacturer Name
Abbott GmbH. & Co. KG
Model Information
Model ID(s)
07P4622
Product Accessories

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