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BD CD4 (SK3) PerCP-Cy5.5 - HSA Registration DE0510643

Access comprehensive regulatory information for BD CD4 (SK3) PerCP-Cy5.5 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 DE0510643 and owned by Becton, Dickinson and Company, BD Biosciences. The device was registered on April 28, 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.

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CLASS C IVD
DE0510643
BD CD4 (SK3) PerCP-Cy5.5
HSA Registration Number: DE0510643
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Product Description

CD4 (SK3) is intended for in vitro diagnostic use in the identification of cells expressing the CD4 antigen in peripheral blood, using a BD FACSLyric™ flow cytometer.

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0510643
Registration Date
April 28, 2025
Retention Due Date
April 27, 2026
Product Owner
Short Name
Becton, Dickinson and Company, BD Biosciences
Address
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 CD4 (SK3) PerCP-Cy5.5
Model Identifier(s)
332772