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BD Oncomarkโ„ข Kappa/Lambda/CD19 - SFDA Registration ME0000002814SFDAA00180

Access comprehensive regulatory information for BD Oncomarkโ„ข 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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General IVD(Others)
ME0000002814SFDAA00180
BD Oncomarkโ„ข Kappa/Lambda/CD19
SFDA Registration: ME0000002814SFDAA00180
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Product Information

Anti Kappa/Anti Lambda/CD19 for flow cytometer

Product Use

BD Oncomarkโ„ข Anti-Kappa FITC/ Anti-Lambda PE/CD19 PerCP-Cyโ„ข5.5* 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
Model Information
Model ID(s)
331355
Product Accessories

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