IMMULITE/IMMULITE 1000 Systems CMM CMV IgM - SFDA Registration ME0000001481SFDAA00161
Access comprehensive regulatory information for IMMULITE/IMMULITE 1000 Systems CMM CMV 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 ME0000001481SFDAA00161 and manufactured by Siemens Healthcare diagnostics products Limited.
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.
For the Qualitative Detection of IgM Antibodies to Cytomegalovirus (CMV) in Human Serum and Plasma
For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers — for the qualitative detection of IgM antibodies to cytomegalovirus (CMV) in human serum or plasma (EDTA or heparinized), as an aid in the diagnosis of current and recent CMV infection in individuals with signs and symptoms of CMV infection or clinical suspicion of CMV infection. This assay is not FDA cleared or approved for use in testing (screening) blood or plasma donors, neonatal screening, or for use at point-of-care facilities
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