Saudi Arabia SFDA registration ME0000001481SFDAA00843
Enzygnost® HBsAg 6.0
Saudi Arabia·Chemicals·Siemens Healthcare diagnostics products Gmbh·Annex II List AActiveProduct information
for the qualitative detection of hepatitis B in human serum or plasma
Product use
Enzygnost® HBsAg 6.0 is an enzyme immunoassay for the qualitative detection of hepatitis B (surface)
antigen in human serum or plasma. The enzyme immunoassay can be processed using the ELISA processors,
BEP® III System, BEP® 2000 System or BEP 2000 Advance® System, as well as the Quadriga® and Quadriga®
BeFree Systems. A non-automated processing of the test is also possible
Device classification
- Risk Class
- Annex II List A
- Product Category
- Chemicals
- Product Type
- IVD
Registration information
- Registration ID
- ME0000001481SFDAA00843
- Authorization ID
- GHTF-2016-2406
- Status
- Active
- Expire Date
- May 29, 2017
Manufacturer
- Manufacturer Name
- Siemens Healthcare diagnostics products Gmbh
Model information
- Model ID(s)
- OPFM03 and OPFM05
Product accessories
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About this record
Access comprehensive regulatory information for Enzygnost® HBsAg 6.0 in the Saudi Arabia medical device market through Pure Global AI's free database. This Annex II List A device is registered with Saudi Arabia SFDA under registration number ME0000001481SFDAA00843 and manufactured by Siemens Healthcare diagnostics products Gmbh.
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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