Atellica IM cPSA PRE - SFDA Registration ME0000001435SFDAA00954
Access comprehensive regulatory information for Atellica IM cPSA PRE 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 ME0000001435SFDAA00954 and manufactured by Siemens Healthcare diagnostics Inc.
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-PSA-specific mouse monoclonal antibody which blocks the free PSA present in human serum
In the Atellica IM cPSA assay, free PSA present in the sample is prevented from reacting with the total PSA antibodies by incubating the sample with a free-PSA-specific mouse monoclonal antibody (Pretreatment Reagent), which blocks the free PSA so that it is nonreactive in the Atellica IM cPSA assay. The cPSA in the sample is then measured in the Atellica IM cPSA assay.
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