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LIAISON Control Toxo IgM - SFDA Registration ME0000003094SFDAA00053

Access comprehensive regulatory information for LIAISON Control Toxo IgM 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 ME0000003094SFDAA00053 and manufactured by DiaSorin S.p.A..

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
ME0000003094SFDAA00053
LIAISON Control Toxo IgM
SFDA Registration: ME0000003094SFDAA00053
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Product Information

IVD Toxo IgM Negative and Positive Controls used in checking reliability of assay runs

Product Use

The LIAISONยฎ Toxo IgM controls (negative and positive) are to be used in LIAISONยฎ chemiluminescent immunoassays (CLIA) as a means of checking reliability of assay runs. The performance characteristics of LIAISONยฎ Toxo IgM controls have not been established in connection with any other assays or instrument platforms.

Device Classification
Risk Class
Annex II List B
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000003094SFDAA00053
Authorization ID
MDMA-1-2019-4213
Status
Active
Expire Date
May 26, 2025
Manufacturer
Manufacturer Name
DiaSorin S.p.A.
Model Information
Model ID(s)
310711
Product Accessories

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