Saudi Arabia SFDA registration ME0000001435SFDAA01314
Atellica IM EHIV
Saudi Arabia·Chemicals·Siemens Healthcare diagnostics Inc·Annex II List AActiveProduct information
Qualitative test for antibodies to human immunodeficiency virus type 1, O, 2 in serum & plasma
Product use
The Atellica™ IM HIV 1/O/2 Enhanced (EHIV) assay is for in vitro diagnostic use in the qualitative determination of antibodies to human immunodeficiency virus type 1, including subtype O, and/or type 2 in human serum and plasma (EDTA, lithium heparin, and sodium heparin) using the Atellica™ IM Analyzer.
Device classification
- Risk Class
- Annex II List A
- Product Category
- Chemicals
- Product Type
- IVD
Registration information
- Registration ID
- ME0000001435SFDAA01314
- Authorization ID
- GHTF-2019-0422
- Status
- Active
- Expire Date
- December 31, 2019
Manufacturer
- Manufacturer Name
- Siemens Healthcare diagnostics Inc
Model information
- Model ID(s)
- 10995610
Product accessories
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About this record
Access comprehensive regulatory information for Atellica IM EHIV 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 ME0000001435SFDAA01314 and manufactured by Siemens Healthcare diagnostics Inc.
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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