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Enzygnost® HBsAg 6.0 - SFDA Registration ME0000001481SFDAA00843

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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SFDA Official Data
Annex II List A
ME0000001481SFDAA00843
Enzygnost® HBsAg 6.0
SFDA Registration: ME0000001481SFDAA00843
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Product 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
Model Information
Model ID(s)
OPFM03 and OPFM05
Product Accessories

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