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BD OneFlow™ PCST - HSA Registration DE0503461

Access comprehensive regulatory information for BD OneFlow™ PCST 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 DE0503461 and owned by Becton, Dickinson and Company, BD Biosciences. The device was registered on August 13, 2019.

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
DE0503461
BD OneFlow™ PCST
HSA Registration Number: DE0503461
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Product Description

The BD OneFlow™ PCST (Plasma Cell Screening Tube) is intended for flow cytometric immunophenotyping of normal polyclonal and aberrant plasma cell populations in bone marrow as an aid in the diagnosis of hematological disorders. The BD OneFlow PCST tube is designed for use with a suitably equipped BD flow cytometer and software designated for in vitro diagnostic use.

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0503461
Registration Date
August 13, 2019
Change Notification Approval Date
January 23, 2024
Retention Due Date
August 12, 2025
Product Owner
Short Name
Becton, Dickinson and Company, BD Biosciences
Address
2350 Qume Drive, San Jose, California, 95131, 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 OneFlow™ Assays System BD OneFlow™ PCST
Model Identifier(s)
659305 659912