Saudi Arabia SFDA registration ME0000001435SFDAA00954
Atellica IM cPSA PRE
Saudi Arabia·Chemicals·Siemens Healthcare diagnostics Inc·Annex II List BActiveProduct information
Free-PSA-specific mouse monoclonal antibody which blocks the free PSA present in human serum
Product use
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.
Device classification
- Risk Class
- Annex II List B
- Product Category
- Chemicals
- Product Type
- IVD
Registration information
- Registration ID
- ME0000001435SFDAA00954
- Authorization ID
- GHTF-2017-0252
- Status
- Active
- Expire Date
- December 31, 2019
Manufacturer
- Manufacturer Name
- Siemens Healthcare diagnostics Inc
Model information
- Model ID(s)
- 10995546
Product accessories
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About this record
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.
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