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Singapore HSA registration DE0510228

BD Anti-HLA-DR (L243)

Singapore flagSingapore·CLASS C IVD·Becton, Dickinson & Company·Registered January 09, 2025
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Clinical chemistry
Registration information
Registration Number
DE0510228
Registration Date
January 09, 2025
Retention Due Date
January 08, 2026
Product description
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
Name
Becton, Dickinson & Company
Short Name
Becton, Dickinson & Company
Address
Becton, Dickinson and Company, BD Biosciences, 155 North McCarthy Boulevard, Milpitas, California 95035, UNITED STATES
Registrant
Name
BECTON DICKINSON HOLDINGS PTE. LTD.
Address
10 COLLYER QUAY, OCEAN FINANCIAL CENTRE, #10-01, SINGAPORE 049315
Importer
Name
BECTON DICKINSON HOLDINGS PTE. LTD.
Address
10 COLLYER QUAY, OCEAN FINANCIAL CENTRE, #10-01, SINGAPORE 049315
Model information
Model Name(s)
BD Anti–HLA-DR (L243) PE-Cy7 BD Anti–HLA-DR (L243) PerCP-Cy5.5 BD Anti–HLA-DR (L243) V450
Model Identifier(s)
335830 339216 655874
About this record

Access comprehensive regulatory information for BD Anti-HLA-DR (L243) 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 DE0510228 and owned by Becton, Dickinson & Company. The device was registered on January 09, 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