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Alinity i Toxo IgG Calibrators - SFDA Registration ME0000002987SFDAA00332

Access comprehensive regulatory information for Alinity i Toxo IgG Calibrators 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 ME0000002987SFDAA00332 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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Annex II List B
ME0000002987SFDAA00332
Alinity i Toxo IgG Calibrators
SFDA Registration: ME0000002987SFDAA00332
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Product Information

Calibrators for the quantitative determination of IgG antibodies to Toxoplasma gondii

Product Use

The Alinity i Toxo IgG Calibrators are for the calibration of the Alinity i analyzer when used for the quantitative determination of IgG antibodies to Toxoplasma gondii in human serum and plasma. For additional information, refer to the Alinity i Toxo IgG reagent package insert and the Alinity ci-series Operations Manual

Device Classification
Risk Class
Annex II List B
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000002987SFDAA00332
Authorization ID
GHTF-2019-2945
Status
Active
Expire Date
May 27, 2024
Manufacturer
Manufacturer Name
Abbott GmbH. & Co. KG
Model Information
Model ID(s)
07P4501
Product Accessories

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