Saudi Arabia SFDA registration ME0000001435SFDAA00952
Atellica IM fPSA
Saudi Arabia·Chemicals·Siemens Healthcare diagnostics Inc·Annex II List BActiveProduct information
Quantitative measurement for free prostate-specific antigen in human serum
Product use
"The Atellica™ IM Free Prostate‑Specific Antigen (fPSA) assay is for in vitro diagnostic use in the quantitative measurement of free prostate‑specific antigen in human serum using the Atellica™ IM Analyzer.
The Atellica IM fPSA assay is intended to be used in conjunction with the Atellica IM PSA assay in men aged 50 years or older with total PSA values between 4 and 10 ng/mL and a digital rectal exam (DRE) non‑suspicious for cancer to determine the percent free PSA value. The percent free PSA value can be used as an aid in discriminating between prostate cancer and benign prostatic disease. Prostate biopsy is required for the diagnosis of prostate cancer."
Device classification
- Risk Class
- Annex II List B
- Product Category
- Chemicals
- Product Type
- IVD
Registration information
- Registration ID
- ME0000001435SFDAA00952
- Authorization ID
- GHTF-2017-0252
- Status
- Active
- Expire Date
- December 31, 2019
Manufacturer
- Manufacturer Name
- Siemens Healthcare diagnostics Inc
Model information
- Model ID(s)
- 10995577
Product accessories
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About this record
Access comprehensive regulatory information for Atellica IM fPSA 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 ME0000001435SFDAA00952 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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