Singapore HSA registration DE0509305
BD CD57 (HNK-1) FITC
Singapore·CLASS C IVD·Becton, Dickinson & Company·Registered May 21, 2024Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0509305
- Registration Date
- May 21, 2024
- Retention Due Date
- May 20, 2025
Product description
CD57 (NHK-1) is intended for in vitro diagnostic use in the identification of cells expressing CD57 antigen, using a BD FACS™ brand flow cytometer. Clinical applications: expression of the CD57 antigen in the characterization of subjects having, or suspected of having hematological neoplasia. CD57 (HNK-1) is a qualitative reagent intended for laboratory professional use only.
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 CD57 (HNK-1) FITC
- Model Identifier(s)
- 333169
About this record
Access comprehensive regulatory information for BD CD57 (HNK-1) FITC 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 DE0509305 and owned by Becton, Dickinson & Company. The device was registered on May 21, 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