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Enzygnost® HIV Integral 4 - SFDA Registration ME0000001481SFDAA00845

Access comprehensive regulatory information for Enzygnost® HIV Integral 4 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 ME0000001481SFDAA00845 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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Annex II List A
ME0000001481SFDAA00845
Enzygnost® HIV Integral 4
SFDA Registration: ME0000001481SFDAA00845
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Product Information

for the qualitative detection of HIV p24 antigen and specific antibodies to human

Product Use

The enzyme immunoassay can be processed using the ELISA processors, BEP® III System, BEP® 2000 System, BEP 2000 Advance® System as well as the Quadriga® Systems. A non‑automated processing of the test is also possible. For in vitro diagnostic use

Device Classification
Risk Class
Annex II List A
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000001481SFDAA00845
Authorization ID
GHTF-2016-2406
Status
Active
Expire Date
May 29, 2017
Model Information
Model ID(s)
OPKR03 and OPKR05
Product Accessories

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