Saudi Arabia SFDA registration ME0000002814SFDAA00255
BD Oncomark™ CD8/CD56/CD3
Saudi Arabia·Chemicals·Becton, Dickinson and Company, BD Biosciences·General IVD(Others)ActiveProduct information
Anti CD8/CD56/CD3 for flow cytometer
Product use
BD Oncomark™ CD8 FITC/CD56 PE/
CD3 PerCP-Cy™5.5* is intended for in
vitro flow cytometric
immunophenotyping of normal and
abnormal populations of large granular
lymphocytes.1-4 These types of cells
express the CD56 antigen and frequently
are dimly stained with CD8.5 Cells of
natural killer (NK) origin are CD3
negative.5 A subset of CD3-positive T
cells express the CD56 antigen.6 T and
non-T variants of NK lymphoproliferative
disorder have been recognized,1,4
including aggressive variants.3,7 CD8/
CD56/CD3 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
- ME0000002814SFDAA00255
- Authorization ID
- GHTF-2017-0924
- Status
- Active
- Expire Date
- June 21, 2023
Manufacturer
- Manufacturer Name
- Becton, Dickinson and Company, BD Biosciences
Model information
- Model ID(s)
- 333171
Product accessories
[]
About this record
Access comprehensive regulatory information for BD Oncomark™ CD8/CD56/CD3 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 ME0000002814SFDAA00255 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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