HSA · registration DE0510329BD CD13 (L138) PE
SingaporeClinical chemistryClass CBecton, Dickinson & Company
Official record identity
- Registration number
- DE0510329
- Model name
- BD CD13 (L138) PE
- Model identifier
- 347406
- Registration date
- February 12, 2025
Classification
- Risk class
- Class C
Official value: CLASS C
Published parties
- Product owner
- Becton, Dickinson & Company
- Registrant / registration holder
- BECTON DICKINSON HOLDINGS PTE. LTD.
Official 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.
Additional source fields
- Product owner address
- Becton, Dickinson and Company, BD Biosciences, 155 North McCarthy Boulevard, Milpitas, California 95035, United States
- Registrant address
- 10 COLLYER QUAY, #10-01, OCEAN FINANCIAL CENTRE, Singapore 049315
About this record
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.