Saudi Arabia SFDA registration ME0000003094SFDAA00056
LIAISON Control CMV IgG II
Saudi Arabia·Chemicals·DiaSorin S.p.A.·Annex II List BActiveProduct information
IVD CMV IgG II Controls used in CLIA as means of checking reliability of assay runs
Product use
The LIAISON® CMV IgG II controls (negative and positive) are to be used in LIAISON® chemiluminescence immunoassays (CLIA) as a means of checking reliability of assay runs. The performance characteristics of LIAISON® CMV IgG II controls have not been established for any other assays or instrument platforms different from LIAISON® and LIAISON® XL®.
LIAISON® 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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About this record
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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