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BD CD3 (SK7) - HSA Registration DE0509765

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.

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CLASS C IVD
DE0509765
BD CD3 (SK7)
HSA Registration Number: DE0509765
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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.

Device 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 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