BD Multitest™ IMK Kit - HSA Registration DE0504303
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.
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.