Saudi Arabia SFDA registration ME0000001435SFDAA00967
Atellica IM fPSA CAL
Saudi Arabia·Chemicals·Siemens Healthcare diagnostics Inc·Annex II List BActiveProduct information
Calibrator for free prostate-specific antigen assay
Product use
The Atellica™ IM Free Prostate-Specific Antigen Calibrator (fPSA CAL) is for in vitro diagnostic use in calibrating the Atellica IM fPSA assay using the Atellica™ IM Analyzer.
Device classification
- Risk Class
- Annex II List B
- Product Category
- Chemicals
- Product Type
- IVD
Registration information
- Registration ID
- ME0000001435SFDAA00967
- Authorization ID
- GHTF-2017-0252
- Status
- Active
- Expire Date
- December 31, 2019
Manufacturer
- Manufacturer Name
- Siemens Healthcare diagnostics Inc
Model information
- Model ID(s)
- 10995578
Product accessories
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About this record
Access comprehensive regulatory information for Atellica IM fPSA CAL 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 ME0000001435SFDAA00967 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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