Saudi Arabia SFDA registration ME0000001435SFDAA00958
Atellica IM cPSA QC
Saudi Arabia·Chemicals·Siemens Healthcare diagnostics Inc·Annex II List BActiveProduct information
Quality control for complexed prostate-specific antigen assay
Product use
The Atellica™ IM Complexed Prostate‑Specific Antigen Quality Control (cPSA QC) is for in vitro diagnostic use in monitoring the precision and the accuracy of the Atellica IM cPSA assay using the Atellica™ IM Analyzer.
Device classification
- Risk Class
- Annex II List B
- Product Category
- Chemicals
- Product Type
- IVD
Registration information
- Registration ID
- ME0000001435SFDAA00958
- Authorization ID
- GHTF-2017-0252
- Status
- Active
- Expire Date
- December 31, 2019
Manufacturer
- Manufacturer Name
- Siemens Healthcare diagnostics Inc
Model information
- Model ID(s)
- 10995547
Product accessories
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About this record
Access comprehensive regulatory information for Atellica IM cPSA QC 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 ME0000001435SFDAA00958 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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