Saudi Arabia SFDA registration ME0000002814SFDAA00147
BD™ Stem Cell Enumeration Kit
Saudi Arabia·Chemicals·Becton, Dickinson and Company, BD Biosciences·General IVD(Others)ActiveProduct information
simultaneous enumeration of viable dual-positive CD45+/CD34+ hematopoietic stem cell
Product use
The BD™ 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 FACSCalibur™ using BD CellQuest™ (Pro) software or a BD FACSCanto™ II using BD FACSCanto™ 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
Manufacturer
- Manufacturer Name
- Becton, Dickinson and Company, BD Biosciences
Model information
- Model ID(s)
- 344563
Product accessories
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About this record
Access comprehensive regulatory information for BD™ 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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