Saudi Arabia SFDA registration ME0000002987SFDAA00329
Alinity i Toxo IgM Reagent Kit
Saudi Arabia·Chemicals·Abbott GmbH. & Co. KG·Annex II List BActiveProduct information
Qualitative detection of IgM
antibodies to Toxoplasma gondii
Product use
The Alinity i Toxo IgM assay is a chemiluminescent microparticle
immunoassay (CMIA) used for the qualitative detection of IgM
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
- ME0000002987SFDAA00329
- Authorization ID
- GHTF-2019-2945
- Status
- Active
- Expire Date
- May 27, 2024
Manufacturer
- Manufacturer Name
- Abbott GmbH. & Co. KG
Model information
- Model ID(s)
- 07P4722,07P4732
Product accessories
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About this record
Access comprehensive regulatory information for Alinity i Toxo IgM 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 ME0000002987SFDAA00329 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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