Singapore HSA registration DE0509765
BD CD3 (SK7)
Singapore·CLASS C IVD·Becton, Dickinson & Company·Registered September 10, 2024Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0509765
- Registration Date
- September 10, 2024
- Change Notification Approval Date
- October 07, 2024
- Retention Due Date
- September 09, 2025
Product description
CD3 (SK7) is intended for in vitro diagnostic use in the identification of cells expressing the CD3 antigen in peripheral blood, using a BD FACSLyric™ flow cytometer. Expression of the CD3 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 CD3 (SK7) PerCP-Cy5.5 BD CD3 (SK7) APC-H7
- Model Identifier(s)
- 332771 641415
About this record
Access comprehensive regulatory information for BD CD3 (SK7) 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 DE0509765 and owned by Becton, Dickinson & Company. The device was registered on September 10, 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