Singapore HSA registration DE0509840
BD CD45RA (L48) PE-Cy7
Singapore·CLASS C IVD·Becton, Dickinson & Company·Registered September 25, 2024Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0509840
- Registration Date
- September 25, 2024
- Retention Due Date
- September 24, 2025
Product description
CD45RA(L48) is intended for invitro diagnostic use in the identification of cells expressing the CD45RA antigen in peripheral blood, using a BD FACSLyric™ flow cytometer. Expression of the CD45RA antigen in the characterization of subjects having, or suspected of having hematological neoplasia.
Product Owner
- Short Name
- Becton, Dickinson & Company
- Address
- Becton, Dickinson and Company, BD Biosciences, 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 CD45RA (L48) PE-Cy7
- Model Identifier(s)
- 337186
About this record
Access comprehensive regulatory information for BD CD45RA (L48) PE-Cy7 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 DE0509840 and owned by Becton, Dickinson & Company. The device was registered on September 25, 2024.
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