Saudi Arabia SFDA registration ME0000004465SFDAA00009
Anti-B BioClone
Saudi Arabia·Chemicals·Ortho Clinical Diagnostics·Annex II List AActiveProduct information
ABO Sera
Product use
Qualitative test with blended monoclonal antibodies for recognition of the A (ABO1) antigen and its subgroups and/or
the B (ABO2) antigen on human red blood cells
FOR IN VITRO DIAGNOSTIC USE
Device classification
- Risk Class
- Annex II List A
- Product Category
- Chemicals
- Product Type
- IVD
Registration information
- Registration ID
- ME0000004465SFDAA00009
- Authorization ID
- GHTF-2015-0888
- Status
- Active
- Expire Date
- July 08, 2017
Manufacturer
- Manufacturer Name
- Ortho Clinical Diagnostics
Model information
- Model ID(s)
- 711328
Product accessories
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About this record
Access comprehensive regulatory information for Anti-B BioClone 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 ME0000004465SFDAA00009 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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