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Alinity i Toxo IgM Calibrator - SFDA Registration ME0000002987SFDAA00333

Access comprehensive regulatory information for Alinity i Toxo IgM Calibrator 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 ME0000002987SFDAA00333 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
ME0000002987SFDAA00333
Alinity i Toxo IgM Calibrator
SFDA Registration: ME0000002987SFDAA00333
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Product Information

Calibrator for the qualitative detection of IgM antibodies to Toxoplasma gondii

Product Use

The Alinity i Toxo IgM Calibrator is for the calibration of the Alinity i analyzer when used for the qualitative detection of IgM antibodies to Toxoplasma gondii in human serum and plasma. For additional information, refer to the Alinity i Toxo IgM 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
ME0000002987SFDAA00333
Authorization ID
GHTF-2019-2945
Status
Active
Expire Date
May 27, 2024
Manufacturer
Manufacturer Name
Abbott GmbH. & Co. KG
Model Information
Model ID(s)
07P4701
Product Accessories

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