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BDโ„ข Stem Cell Enumeration Kit - SFDA Registration ME0000002814SFDAA00147

Access comprehensive regulatory information for BDโ„ข Stem Cell Enumeration Kit 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 ME0000002814SFDAA00147 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)
ME0000002814SFDAA00147
BDโ„ข Stem Cell Enumeration Kit
SFDA Registration: ME0000002814SFDAA00147
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Product Information

simultaneous enumeration of viable dual-positive CD45+/CD34+ hematopoietic stem cell

Product Use

The BDโ„ข Stem Cell Enumeration kit provides simultaneous enumeration of viable dual-positive CD45+/CD34+ hematopoietic stem cell populations in CD34+ absolute counts as well as the percentage of the total viable leucocyte count that is CD34+.The following specimens can be analyzed: normal and mobilized peripheral blood, fresh and thawed leucopheresis products, bone marrow and cord blood. The kit is intended for IVD use on either a BD FACSCaliburโ„ข using BD CellQuestโ„ข (Pro) software or a BD FACSCantoโ„ข II using BD FACSCantoโ„ข software

Device Classification
Risk Class
General IVD(Others)
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000002814SFDAA00147
Authorization ID
GHTF-2017-0905
Status
Active
Expire Date
May 27, 2023
Model Information
Model ID(s)
344563
Product Accessories

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