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Enzygnost Anti-HBc monoclonal - SFDA Registration ME0000001481SFDAA00847

Access comprehensive regulatory information for Enzygnost Anti-HBc 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 ME0000001481SFDAA00847 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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SFDA Official Data
Annex II List A
ME0000001481SFDAA00847
Enzygnost Anti-HBc monoclonal
SFDA Registration: ME0000001481SFDAA00847
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Product Information

for qualitative detection of specific antibodies to Hepatitis B

Product Use

Enzyme immunoassay for the qualitative detection of specific antibodies to Hepatitis B (core)-Antigen in human serum or plasma. The enzyme immunoassay can be processed using the ELISA processors, BEPยฎ III System, BEPยฎ 2000 System or the BEP 2000 Advanceยฎ System. 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
ME0000001481SFDAA00847
Authorization ID
GHTF-2016-2406
Status
Active
Expire Date
May 29, 2017
Model Information
Model ID(s)
OUWE17 and OUWE19
Product Accessories

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