Saudi Arabia SFDA registration ME0000004465SFDAA00005
0.8% Affirmagen® 4
Saudi Arabia·Chemicals·Ortho Clinical Diagnostics·Annex II List AActiveProduct information
ABO Grouping Cells
Product use
For use with Ortho BioVue® System to confirm the ABO forward (red cell) group
FOR IN VITRO DIAGNOSTIC USE
Device classification
- Risk Class
- Annex II List A
- Product Category
- Chemicals
- Product Type
- IVD
Registration information
- Registration ID
- ME0000004465SFDAA00005
- Authorization ID
- GHTF-2015-0888
- Status
- Active
- Expire Date
- July 08, 2017
Manufacturer
- Manufacturer Name
- Ortho Clinical Diagnostics
Model information
- Model ID(s)
- 719221
Product accessories
[]
About this record
Access comprehensive regulatory information for 0.8% Affirmagen® 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 ME0000004465SFDAA00005 and manufactured by Ortho Clinical Diagnostics.
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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