Pure Global

Enzygnost Anti-HCV 4.0 - SFDA Registration ME0000001481SFDAA00842

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.

Free Database
Powered by Pure Global AI
SFDA Official Data
Annex II List A
ME0000001481SFDAA00842
Enzygnost Anti-HCV 4.0
SFDA Registration: ME0000001481SFDAA00842
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product 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 BEPยฎ III System, BEPยฎ 2000 System or BEP 2000 Advanceยฎ System as well as the Quadrigaยฎ 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
Model Information
Model ID(s)
OPIH03 and OPIH05
Product Accessories

[]