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BD CD13 (L138) PE - HSA Registration DE0510329

Access comprehensive regulatory information for BD CD13 (L138) PE 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 DE0510329 and owned by Becton, Dickinson & Company. The device was registered on February 12, 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
DE0510329
BD CD13 (L138) PE
HSA Registration Number: DE0510329
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Product Description

CD13 (L138) is intended for in vitro diagnostic use in the identification of cells expressing the CD13 antigen in peripheral blood, using a BD FACSLyric™ flow cytometer. Expression of the CD13 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
DE0510329
Registration Date
February 12, 2025
Retention Due Date
February 11, 2026
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 CD13 (L138) PE
Model Identifier(s)
347406