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BD Oncomarkโ„ข CD45/GlyA/CD41a - SFDA Registration ME0000002814SFDAA00179

Access comprehensive regulatory information for BD Oncomarkโ„ข CD45/GlyA/CD41a in the Saudi Arabia medical device market through Pure Global AI's free database. This General IVD(Others) device is registered with Saudi Arabia SFDA under registration number ME0000002814SFDAA00179 and manufactured by Becton, Dickinson and Company, BD Biosciences.

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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General IVD(Others)
ME0000002814SFDAA00179
BD Oncomarkโ„ข CD45/GlyA/CD41a
SFDA Registration: ME0000002814SFDAA00179
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Product Information

Anti CD45/Glycophorin A/CD41a for flow cytometer

Product Use

BD Oncomarkโ„ข CD45 FITC/Antiโ€“ glycophorin A PE/CD41a PerCPCy โ„ข5.5* is intended for in vitro flow cytometric immunophenotyping of the development in the erythroid, leucocytic, and megakaryocytic cell lineages in peripheral blood and bone marrow. Megakaryocytes co-express the plateletspecific glycoprotein gpIIb/IIIa (CD41a) and CD45 throughout their differentiation.1 In contrast, glycophorin A expression is present during erythroid cell development, with a gradual decrease in CD45 intensity during erythroid maturation. Using this approach, erythroid and lymphoid cells can be clearly distinguished based upon their antigenic expression.2 CD45/Antiโ€“ glycophorin A/CD41a assays are used in the diagnosis of hematologic disorders.

Device Classification
Risk Class
General IVD(Others)
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000002814SFDAA00179
Authorization ID
GHTF-2017-0908
Status
Active
Expire Date
May 08, 2023
Model Information
Model ID(s)
333175
Product Accessories

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