CE Certification Studies

  • Fatty acids with extended chains, pristanic acid, phytanic acid: Carried out as a Tübitak R&D reduction project in 2009 and was approved within the scope of the Corporate Tax General Communiqué Serial No. 1, of the Ministry of Finance Revenue Administration.
  • HBsAg (immunochromatography): CE certification done. (The study was carried out according to Directive 98/79/EC European Parliament and Council and reported to the Czech Republic Accreditation Agency.) (The lot controls of this test is carried out continuously.)
  • Anti-HBs (immunochromatography): CE certification done. (The study was carried out according to Directive 98/79/EC European Parliament and Council and reported to the Czech Republic Accreditation Agency.) (The lot controls of this test is carried out continuously.)
  • Anti-HCV (immunochromatography): CE certification was made (The study was carried out according to Directive 98/79/EC European Parliament and Council and reported to the Czech Republic Accreditation Agency.) (The lot controls of this test is carried out continuously.)
  • Anti-HIV (immunochromatography): CE certification was made (The study was carried out according to Directive 98/79/EC European Parliament and Council and reported to the Czech Republic Accreditation Agency.) (The lot controls of this test is carried out continuously.)
  • Phenylalanine (LC-MS/MS): LC-MS/MS kit CE certification study was performed.
  • Vitamin D (LC-MS/MS): CE certification study was performed for LC-MS/MS calibrators and controls.
  • Amino acid (LC-MS/MS): CE certification study was performed for LC-MS/MS calibrators and controls.
  • Vitamin D (immunoassay): Global pre-market trial studies (Early adopter program) of the Roche Cobas Vitamin D Total kit were performed. Presented at IFCC 2011WorlLab Berlin. It was presented as a selected center study in Grainau in 2012. It is planned to be published in a multicentered global study.
  • Neonatal TSH (ELISA): In the project phase.
  • VDRL (immunochromatography): In the project phase.
  • AMH (Anti Müllerian hormone) (Immunoassay): In project phase