Kobay Deney Hayvanları Laboratuvarı A.Ş. is a contract research and testing laboratory in Ankara, founded on 12 September 2008. It started as Türkiye's first private laboratory animal production facility and now also tests medical devices for manufacturers.For medical device companies, Kobay carries out biocompatibility tests such as cytotoxicity, sensitisation, irritation, implantation, hemolysis, pyrogenicity, systemic toxicity and genotoxicity, as well as sterility, microbiology and chemical characterisation tests. It also offers GLP preclinical studies, clinical research management and consulting on EU MDR/IVDR, US FDA and biological safety. Other services include veterinary diagnostic laboratories and scanning electron microscopy.The laboratory holds TÜRKAK TS EN ISO 17025:2017 accreditation, a TÜRKAK OECD GLP compliance statement and GMP and GCP certificates from the Turkish Medicines and Medical Devices Agency (TİTCK). It is an approved R&D centre.
Medical Device Biocompatibility TestingCytotoxicity TestingSensitization And Irritation TestingImplantation TestingHemolysis And Pyrogenicity TestingSystemic Toxicity And Genotoxicity TestingSterility And Microbiology TestingChemical Characterization TestingGLP Preclinical StudiesClinical Research ManagementEU MDR And IVDR ConsultingUS FDA ConsultingVeterinary Diagnostic Laboratory ServicesScanning Electron Microscopy (SEM)Laboratory Animal Supply
TÜRKAK TS EN ISO 17025:2017 accreditation, TÜRKAK OECD GLP compliance, TİTCK GMP certificate, TİTCK GCP certificate
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