Saudi Arabia SFDA registration ME0000001481SFDAA00160
IMMULITE/IMMULITE 1000 Systems PSA PSA
Saudi Arabia·Chemicals·Siemens Healthcare diagnostics products Limited·Annex II List BActiveProduct information
For the quantitative measurement of prostate - specific antigen (PSA) in human serum
Product use
for the quantitative measurement of prostate specific antigen (PSA)in human serum , as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older , this assay is further indicated as an adjunctive test to aid in hte management of prostate cancer patients ,
Device classification
- Risk Class
- Annex II List B
- Product Category
- Chemicals
- Product Type
- IVD
Registration information
- Registration ID
- ME0000001481SFDAA00160
- Authorization ID
- GHTF-2019-5843
- Status
- Active
- Expire Date
- December 31, 2019
Manufacturer
- Manufacturer Name
- Siemens Healthcare diagnostics products Limited
Model information
- Model ID(s)
- LKPS1 and LKPS5
Product accessories
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About this record
Access comprehensive regulatory information for IMMULITE/IMMULITE 1000 Systems PSA PSA 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 ME0000001481SFDAA00160 and manufactured by Siemens Healthcare diagnostics products Limited.
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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