Saudi Arabia SFDA registration ME0000002814SFDAA00180
BD Oncomark™ Kappa/Lambda/CD19
Saudi Arabia·Chemicals·Becton, Dickinson and Company, BD Biosciences·General IVD(Others)ActiveProduct information
Anti Kappa/Anti Lambda/CD19 for flow cytometer
Product use
BD Oncomark™ Anti-Kappa FITC/
Anti-Lambda PE/CD19 PerCP-Cy™5.5*
is intended for in vitro flow cytometric
immunophenotyping of the presence and
extent of clonal expansion in
B-lymphoproliferative disorders.
Abnormal kappa/lambda ratios or
intensities are strong indicators of clonal
processes.1,2 Anti-Kappa/Anti-Lambda/
CD19 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
- ME0000002814SFDAA00180
- 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)
- 331355
Product accessories
[]
About this record
Access comprehensive regulatory information for BD Oncomark™ Kappa/Lambda/CD19 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 ME0000002814SFDAA00180 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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