Singapore HSA registration DE0504303
BD Multitest™ IMK Kit
Singapore·CLASS C IVD·Becton, Dickinson and Company, BD Biosciences·Registered April 01, 2020Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0504303
- Registration Date
- April 01, 2020
- Change Notification Approval Date
- October 18, 2024
- Retention Due Date
- March 31, 2026
Product description
The BD Multitest™ IMK Kit with optional BD Trucount™ Tubes is a 4-color direct immunofluorescence reagent kit 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 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 Multitest™ IMK Kit BD Multitest™ IMK Kit Tests with BD Trucount™ Tubes BD Multitest™ IMK Kit
- Model Identifier(s)
- 340503 340504 662965
About this record
Access comprehensive regulatory information for BD Multitest™ IMK Kit 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 DE0504303 and owned by Becton, Dickinson and Company, BD Biosciences. The device was registered on April 01, 2020.
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