DiaSorin LIAISON QuantiFERON-TB Gold Plus - HSA Registration DE0507389
Access comprehensive regulatory information for DiaSorin LIAISON QuantiFERON-TB Gold Plus 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 DE0507389 and owned by DiaSorin Italia S.p.A.. The device was registered on October 21, 2022.
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 DiaSorin LIAISON® QuantiFERON®-TB Gold Plus assay uses chemiluminescent immunoassay (CLIA) technology for the detection of interferon-γ (IFN-γ) in human lithium heparin plasma specimens. The immunoassay can identify in vitroresponses to a peptide antigens cocktail associated with Mycobacterium tuberculosis (M. tuberculosis) infection (including disease) that stimulates cells in heparinized whole blood collected with the QuantiFERON®-TB Gold Plus Blood Collection Tubes. The assay is an indirect test intended as an aid in the diagnosis of M. tuberculosis infection. Although the assay quantitatively detects the IFN-γ, the interpretation of the result for a single patient is strictly qualitative. The assay must be performed on the LIAISON® XL and LIAISON® XS analyzers only.