Singapore HSA registration DE0018401
BD OneFlow™ LST
Singapore·CLASS C IVD·Becton, Dickinson and Company, BD Biosciences·Registered July 25, 2016Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0018401
- Registration Date
- July 25, 2016
- Change Notification Approval Date
- September 24, 2024
- Retention Due Date
- July 24, 2025
Product description
The BD OneFlow™ tubes for chronic lymphoproliferative diseases (CLPD) are intended for in vitro diagnostic use for qualitative flow-cytometric immunophenotyping of mature lymphocyte populations. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having, B-cell CLPD, T-cell CLPD, and NK-cell CLPD. These tubes can be used with peripheral blood and bone marrow specimens collected in EDTA or heparin tubes and lymph node specimens. The results should be interpreted by a pathologist or equivalent professional in conjunction with other clinical or laboratory findings. Antigens targeted by BD OneFlow™ LST are CD8, Igλ, CD56, Igκ, CD5, CD19, TCRγ/δ, CD3, CD38, CD20, CD4 and CD45.
Product Owner
- Short Name
- Becton, Dickinson and Company, BD Biosciences
- Address
- 155 North McCarthy Boulevard, Milpitas, California, 95035, UNITED STATES
Registrant
- Address
- 10 COLLYER QUAY, OCEAN FINANCIAL CENTRE, #10-01, SINGAPORE 049315
Importer
- Address
- 10 COLLYER QUAY, OCEAN FINANCIAL CENTRE, #10-01, SINGAPORE 049315
Model information
- Model Name(s)
- BD OneFlow™ LST
- Model Identifier(s)
- 658619
About this record
Access comprehensive regulatory information for BD OneFlow™ LST in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0018401 and owned by Becton, Dickinson and Company, BD Biosciences. The device was registered on July 25, 2016.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD