Saudi Arabia SFDA registration ME0000002814SFDAA00176
BD Oncomark™ CD7/CD33
Saudi Arabia·Chemicals·Becton, Dickinson and Company, BD Biosciences·General IVD(Others)ActiveProduct information
Anti CD7 and anti CD33 for flow cytometer
Product use
BD Oncomark™ CD7 FITC/CD33 PE is
intended for in vitro flow cytometric
immunophenotyping. This reagent combination
can be used to study expression of
the CD7 antigen in myeloid lineages.
CD33 is useful in identifying myeloid lineage
cells.1 CD7, normally expressed in
T and natural killer (NK) cells, is frequently
aberrantly expressed in acute
myeloid leukemia (AML), and could be
used in the diagnosis of these diseases.2-6
CD7/CD33 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
- ME0000002814SFDAA00176
- 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)
- 333176
Product accessories
[]
About this record
Access comprehensive regulatory information for BD Oncomark™ CD7/CD33 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 ME0000002814SFDAA00176 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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