Singapore HSA registration DE0503461
BD OneFlow™ PCST
Singapore·CLASS C IVD·Becton, Dickinson and Company, BD Biosciences·Registered August 13, 2019Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0503461
- Registration Date
- August 13, 2019
- Change Notification Approval Date
- January 23, 2024
- Retention Due Date
- August 12, 2025
Product description
The BD OneFlow™ PCST (Plasma Cell Screening Tube) is intended for flow cytometric immunophenotyping of normal polyclonal and aberrant plasma cell populations in bone marrow as an aid in the diagnosis of hematological disorders. The BD OneFlow PCST tube is designed for use with a suitably equipped BD flow cytometer and software designated for in vitro diagnostic use.
Product Owner
- Short Name
- Becton, Dickinson and Company, BD Biosciences
- Address
- 2350 Qume Drive, San Jose, California, 95131, 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™ PCST
- Model Identifier(s)
- 659305 659912
About this record
Access comprehensive regulatory information for BD OneFlow™ PCST 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 DE0503461 and owned by Becton, Dickinson and Company, BD Biosciences. The device was registered on August 13, 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