Saudi Arabia SFDA registration ME0000002987SFDAA00331
Alinity i Toxo IgM Controls
Saudi Arabia·Chemicals·Abbott GmbH. & Co. KG·Annex II List BActiveProduct information
Controls for the qualitative detection of IgM antibodies to
Toxoplasma gondii
Product use
The Alinity i Toxo IgM Controls are for the estimation of test precision
and the detection of systematic analytical deviations 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
- ME0000002987SFDAA00331
- Authorization ID
- GHTF-2019-2945
- Status
- Active
- Expire Date
- May 27, 2024
Manufacturer
- Manufacturer Name
- Abbott GmbH. & Co. KG
Model information
- Model ID(s)
- 07P4710
Product accessories
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About this record
Access comprehensive regulatory information for Alinity i Toxo IgM Controls 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 ME0000002987SFDAA00331 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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