Saudi Arabia SFDA registration ME0000001481SFDAA00844
Enzygnost HBe monoclonal
Saudi Arabia·Chemicals·Siemens Healthcare diagnostics products Gmbh·Annex II List AActiveProduct information
for the detection of hepatitis B antigen
in serum and plasma
Product use
HBe antigen and the corresponding antibody anti-HBe are found exclusively in connection with hepatitis B virus
infection. The HBe antigen is frequently indicative of an acute infection but also occurs in chronic hepatitides1,2.
HBe antigen appears already in the early phase of a hepatitis B infection. Using a sensitive immunoassay, it can
be detected shortly after or sometimes almost at the same time as the increase in serum HBsAg3,4.
Device classification
- Risk Class
- Annex II List A
- Product Category
- Chemicals
- Product Type
- IVD
Registration information
- Registration ID
- ME0000001481SFDAA00844
- 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)
- OQDM11
Product accessories
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About this record
Access comprehensive regulatory information for Enzygnost HBe monoclonal 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 ME0000001481SFDAA00844 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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