Singapore HSA registration DE0510293
BD CD25 (2A3) PE
Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Hematology
Registration information
- Registration Number
- DE0510293
- Registration Date
- January 31, 2025
- Retention Due Date
- January 30, 2026
Product description
CD25 (2A3) is intended for in vitro diagnostic use in the identification of cells expressing the CD25 antigen in peripheral blood, using a BD FACSLyric™ flow cytometer. Clinical Applications: Expression of the CD25 antigen in the characterization of subjects having, or suspected of having, hematological neoplasia. CD25 (2A3) is a qualitative reagent intended for laboratory professional use only.
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 CD25 (2A3) PE
- Model Identifier(s)
- 341011
About this record
Access comprehensive regulatory information for BD CD25 (2A3) PE 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 DE0510293 and owned by Becton, Dickinson and Company, BD Biosciences. The device was registered on January 31, 2025.
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