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BD Oncomarkโ„ข CD8/CD56/CD3 - SFDA Registration ME0000002814SFDAA00255

Access comprehensive regulatory information for BD Oncomarkโ„ข 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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General IVD(Others)
ME0000002814SFDAA00255
BD Oncomarkโ„ข CD8/CD56/CD3
SFDA Registration: ME0000002814SFDAA00255
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Product Information

Anti CD8/CD56/CD3 for flow cytometer

Product Use

BD Oncomarkโ„ข CD8 FITC/CD56 PE/ CD3 PerCP-Cyโ„ข5.5* 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
Model Information
Model ID(s)
333171
Product Accessories

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