Pure Global

Alinity i Toxo IgM Controls - SFDA Registration ME0000002987SFDAA00331

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.

Free Database
Powered by Pure Global AI
SFDA Official Data
Annex II List B
ME0000002987SFDAA00331
Alinity i Toxo IgM Controls
SFDA Registration: ME0000002987SFDAA00331
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product 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

[]