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Anti-A,B BioClone - SFDA Registration ME0000004465SFDAA00004

Access comprehensive regulatory information for Anti-A,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 ME0000004465SFDAA00004 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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SFDA Official Data
Annex II List A
ME0000004465SFDAA00004
Anti-A,B BioClone
SFDA Registration: ME0000004465SFDAA00004
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Product 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
ME0000004465SFDAA00004
Authorization ID
GHTF-2015-0888
Status
Active
Expire Date
July 08, 2017
Manufacturer
Model Information
Model ID(s)
711528
Product Accessories

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