Singapore HSA registration DE0503377
BD OneFlow™ ALOT
Singapore·CLASS C IVD·Becton, Dickinson and Company, BD Biosciences·Registered July 18, 2019Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0503377
- Registration Date
- July 18, 2019
- Change Notification Approval Date
- March 10, 2025
- Retention Due Date
- July 17, 2025
Product description
The BD OneFlow ALOT (Acute Leukemia Orientation Tube) is intended for in vitro diagnostic use for qualitative flow- cytometric immunophenotyping of immature hematopoietic cell populations (lymphoid and myeloid lineages) on a BD flow cytometer. BD OneFlow ALOT is used as an aid in the screening of hematologically abnormal patients having, or suspected of having, acute lymphoblastic leukemia or acute myeloid leukemia. BD OneFlow ALOT can be used with peripheral whole blood and bone marrow specimens collected in EDTA or heparin. The results should be interpreted by a pathologist or equivalent professional in conjunction with other clinical or laboratory findings.
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™ Assays System BD OneFlow™ ALOT
- Model Identifier(s)
- 659305 660228
About this record
Access comprehensive regulatory information for BD OneFlow™ ALOT 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 DE0503377 and owned by Becton, Dickinson and Company, BD Biosciences. The device was registered on July 18, 2019.
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