Singapore HSA registration DE0007644
BD™ Multitest 6-Color TBNK Reagent
Singapore·CLASS C IVD·Becton, Dickinson & Company·Registered September 22, 2011Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0007644
- Registration Date
- September 22, 2011
- Change Notification Approval Date
- August 26, 2024
- Retention Due Date
- September 21, 2025
Product description
BD Multitest™ 6-Color TBNK reagent with optional BD Trucount™ Tubes is a six-color direct immunofluorescence reagent for use in identifying and determining the percentages and absolute counts of T, B, and natural killer (NK) cells, as well as the CD4 and CD8 subpopulations of T cells, in peripheral blood on a BD flow cytometer. Determining percentages or absolute counts of CD3+CD4+ T lymphocytes is used in monitoring human immunodeficiency virus (HIV)- infected individuals. Determining percentages or absolute counts of CD3+, CD3+CD4+, or CD3+CD8+ T lymphocytes or CD19+ B lymphocytes is used to characterize or monitor some forms of immune deficiency and autoimmune diseases. Determining percentages or absolute counts of CD3– and CD16+ and/or CD56+ NK lymphocytes is used in immunological assessment of hematologically-normal subjects or patients having, or suspected of having, immune deficiency or other immune-mediated diseases.
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 Multitest™ 6-Colour TBNK Reagent with BD Trucount BD Multitest™ 6-Colour TBNK Reagent
- Model Identifier(s)
- 337166 644611
About this record
Access comprehensive regulatory information for BD™ Multitest 6-Color TBNK Reagent 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 DE0007644 and owned by Becton, Dickinson & Company. The device was registered on September 22, 2011.
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD