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Singapore HSA registration DE0510147

BD CD61 (RUU-PL 7F12) FITC

Singapore flagSingapore·CLASS C IVD·Becton, Dickinson and Company, BD Biosciences·Registered December 13, 2024
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Hematology
Registration information
Registration Number
DE0510147
Registration Date
December 13, 2024
Retention Due Date
December 12, 2025
Product description
CD61 (RUU-PL 7F12) is intended for in vitro diagnostic use in the identification of cells expressing the CD61 antigen in peripheral blood, using a BD FACSLyric™ flow cytometer. Clinical Applications: Expression of the CD61 antigen in the characterization of subjects having, or suspected of having, hematological neoplasia. CD61 (RUU-PL 7F12) is a qualitative reagent intended for laboratory professional use only.
Product Owner
Name
Becton, Dickinson and Company, BD Biosciences
Short Name
Becton, Dickinson and Company, BD Biosciences
Address
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 CD61 (RUU-PL 7F12) FITC
Model Identifier(s)
347407
About this record

Access comprehensive regulatory information for BD CD61 (RUU-PL 7F12) 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 DE0510147 and owned by Becton, Dickinson and Company, BD Biosciences. The device was registered on December 13, 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