Saudi Arabia SFDA registration ME0000002814SFDAA00178
BD Oncomark™ CD3/MPO/CD79a
Saudi Arabia·Chemicals·Becton, Dickinson and Company, BD Biosciences·General IVD(Others)ActiveProduct information
Anti CD3/MPO/CD79a for flow cytometer
Product use
BD Oncomark™ CD3 FITC/Anti-MPO
PE/CD79a PerCP-Cy™5.5* is intended
for in vitro flow cytometric
immunophenotyping to determine lineage
of leukemic blast cells. CD3 identifies
lymphocytes in the T lineage; antimyeloperoxidase
(MPO) identifies cells in
the myeloid lineage,1-3 and CD79a
identifies lymphocytes in the B lineage.4
This combination of reagents should be
used with an intracellular staining
technique.5,6 CD3/Anti-MPO/CD79a
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
- ME0000002814SFDAA00178
- 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)
- 333164
Product accessories
[]
About this record
Access comprehensive regulatory information for BD Oncomark™ CD3/MPO/CD79a 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 ME0000002814SFDAA00178 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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