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LIAISON Control CMV IgG II - SFDA Registration ME0000003094SFDAA00056

Access comprehensive regulatory information for LIAISON Control CMV IgG II 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 ME0000003094SFDAA00056 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
ME0000003094SFDAA00056
LIAISON Control CMV IgG II
SFDA Registration: ME0000003094SFDAA00056
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Product Information

IVD CMV IgG II Controls used in CLIA as means of checking reliability of assay runs

Product Use

The LIAISONยฎ CMV IgG II controls (negative and positive) are to be used in LIAISONยฎ chemiluminescence immunoassays (CLIA) as a means of checking reliability of assay runs. The performance characteristics of LIAISONยฎ CMV IgG II controls have not been established for any other assays or instrument platforms different from LIAISONยฎ and LIAISONยฎ XLยฎ. LIAISONยฎ analyzers. The certificate of analysis gives specific information on the lot of controls, which should be manually entered in the analyzer software prior to loading the control vials on board. For details, refer to the analyzer operator's manual.

Device Classification
Risk Class
Annex II List B
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000003094SFDAA00056
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)
310746
Product Accessories

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