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IMMULITE 2000 Syatems PSA PSA - SFDA Registration ME0000001481SFDAA00157

Access comprehensive regulatory information for IMMULITE 2000 Syatems 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 ME0000001481SFDAA00157 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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SFDA Official Data
Annex II List B
ME0000001481SFDAA00157
IMMULITE 2000 Syatems PSA PSA
SFDA Registration: ME0000001481SFDAA00157
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Product 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 with digital rectal examination (DRE)in men aged 50 years or older this assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients

Device Classification
Risk Class
Annex II List B
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000001481SFDAA00157
Authorization ID
GHTF-2019-5843
Status
Active
Expire Date
December 31, 2019
Model Information
Model ID(s)
L2KPS2 and L2KPS6
Product Accessories

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