ISO Certificates
EN ISO 13485:2016/ISO 13485:2016 certificate – Genome Diagnostics B.V.
The scope of the certification entails the design and development, manufacture and distribution of Nucleic Acid Based In Vitro Medical Devices (including software), contract laboratory services and the provision of training and support. This certification also includes the location(s) as identified on the addendum belonging to this certificate.
The scope of the certification entails the design, development, manufacture and distribution of In Vitro Diagnostic Medical Devices (including software) for Canada.
Declarations of conformity
GenDx AlleleSEQR® HLA-C, DPB1 and DQB1
GenDx AlleleSEQR® HLA-A, B and DRB
NGSgo® workflow compatible with Illumina, IVD 98/79/EC
NGSgo®-AmpX v2 IVD 98/79 HLA-A, B and DR
NGSgo®-AmpX v2 IVD 98/79 HLA-C, -DQ, -DP, -G
SBTexcellerator® HLA-A, B and DRB, IVD 98/79
SBTexcellerator® HLA-C, DQB1, DQA1, DPB1 and DPA1, IVD 98/79