Diamex Optitrol Blue - HSA Registration DE0506580
Access comprehensive regulatory information for Diamex Optitrol Blue in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0506580 and owned by Diamex GmBH. The device was registered on January 19, 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.
Optitrol Blue is a multi-marker quality control (QC) sample intended to monitor the performance of in-vitro assays for determination of Anti-HIV-1 IgG, Anti-HBc IgG, Anti-HTLV I IgG, Anti-HCV IgG, HBsAg and Anti-Treponema pallidum IgG in human serum and plasma. Optitrol Blue samples are optimized for assays and platforms including ABBOTT ARCHITECT, ABBOTT Alinity (i/s) and DiaSorin LIAISON and are unassayed controls without target values. These controls must not be used as a substitute for the mandatory manufacturer’s kit controls provided with the assay. Examples of reactivity (no target values) for this control on different test systems can be found at http://www.diamex.com. Optitrol QC results are helpful in determining the precision of testing systems and in identifying sources of variation.