Saudi Arabia SFDA registration ME0000001481SFDAA00846
Enzygnost Anti-HBc/IgM
Saudi Arabia·Chemicals·Siemens Healthcare diagnostics products Gmbh·Annex II List AActiveProduct information
for the qualitative detection of IgM antibodies to
hepatitis B
Product use
Enzyme immunoassay for the qualitative detection of IgM antibodies to hepatitis B (core) antigen in serum
or plasma. The enzyme immunoassay is processed on the BEP® II, BEP® III and BEP® 2000 ELISA processors.
The test was developed for investigation of individual samples, not pooled samples. The product is for
in‑vitro diagnostic use only.
Device classification
- Risk Class
- Annex II List A
- Product Category
- Chemicals
- Product Type
- IVD
Registration information
- Registration ID
- ME0000001481SFDAA00846
- 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)
- OWSE13
Product accessories
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About this record
Access comprehensive regulatory information for Enzygnost Anti-HBc/IgM 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 ME0000001481SFDAA00846 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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