HSA · registration DE0510228BD Anti-HLA-DR (L243)
- Registration number
- DE0510228
- Model name
- BD Anti–HLA-DR (L243) PE-Cy7; BD Anti–HLA-DR (L243) PerCP-Cy5.5; BD Anti–HLA-DR (L243) V450
- Model identifier
- 335830; 339216; 655874
- Registration date
- January 09, 2025
- Risk class
- Class C
- Product owner
- Becton, Dickinson & Company
- Registrant / registration holder
- BECTON DICKINSON HOLDINGS PTE. LTD.
Anti–HLA-DR (L243) is intended for in vitro diagnostic use in the identification of cells expressing the HLA- DR antigen in peripheral blood, using a BD FACSLyric™ flow cytometer. Clinical Applications: Expression of the HLA-DR antigen in the characterization of subjects having, or suspected of having, hematological neoplasia. Anti–HLA-DR (L243) is a qualitative reagent intended for laboratory professional use only
- Product owner address
- Becton, Dickinson and Company, BD Biosciences, 155 North McCarthy Boulevard, Milpitas, California 95035, United States
- Registrant address
- 10 COLLYER QUAY, #10-01, OCEAN FINANCIAL CENTRE, Singapore 049315
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.