Diamex Optitrol NAT Triplex - HSA Registration DE0506850
Access comprehensive regulatory information for Diamex Optitrol NAT Triplex in the Singapore medical device market through Pure Global AI's free database. This CLASS D IVD medical device is registered under HSA registration number DE0506850 and owned by Diamex GmBH. The device was registered on May 11, 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 NAT Triplex is a multi-marker quality control (QC) sample intended to monitor the performance of in-vitro assays which are used for screening human blood, serum and plasma for presence of hepatitis B virus (HBV) DNA, hepatitis C virus (HCV) RNA and human immunodeficiency virus type 1 (HIV-1) RNA. This QC was manufactured for performing NAT assays to get always positive reproducible results which are helpful in determining the precision of testing systems and in identifying sources of variation. Optitrol NAT Triplex is an unassayed extraction and amplification control without target values.