Saudi Arabia SFDA registration ME0000001481SFDAA00842
Enzygnost Anti-HCV 4.0
Saudi Arabia·Chemicals·Siemens Healthcare diagnostics products Gmbh·Annex II List AActiveProduct information
for the qualitative detection of specific IgG and IgM
antibodies to HCV
Product use
Enzyme immunoassay for the qualitative detection of specific IgG and IgM antibodies to HCV (hepatitis C
virus) 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® Systems. A nonautomated
processing of the test is also possible. The product is for in-vitro diagnostic use
Device classification
- Risk Class
- Annex II List A
- Product Category
- Chemicals
- Product Type
- IVD
Registration information
- Registration ID
- ME0000001481SFDAA00842
- 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)
- OPIH03 and OPIH05
Product accessories
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About this record
Access comprehensive regulatory information for Enzygnost Anti-HCV 4.0 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 ME0000001481SFDAA00842 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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