Saudi Arabia SFDA registration ME0000002814SFDAA00179
BD Oncomark™ CD45/GlyA/CD41a
Saudi Arabia·Chemicals·Becton, Dickinson and Company, BD Biosciences·General IVD(Others)ActiveProduct information
Anti CD45/Glycophorin A/CD41a for flow cytometer
Product use
BD Oncomark™ CD45 FITC/Anti–
glycophorin A PE/CD41a PerCPCy
™5.5* 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/Anti–
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
Manufacturer
- Manufacturer Name
- Becton, Dickinson and Company, BD Biosciences
Model information
- Model ID(s)
- 333175
Product accessories
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About this record
Access comprehensive regulatory information for BD Oncomark™ 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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