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
RF-AlleleSEQR_Decl_of_Conformity ANNEX III
RF-AlleleSEQR_Decl_of_Conformity
RF-NGSN_Decl_of_Conformity ANNEX III
RF-AMPX_Decl_of_Conformity ANNEX III
RF-AMPXV2_Decl_of_Conformity ANNEX III
RF-LFK_Decl_of_Conformity NGSgo Library Full Kit
RF-SBTN_Decl_of_Conformity ANNEX III
RF-SBTX_Decl_of_Conformity ANNEX III
RF-KMR_Decl_of_Conformity ANNEX III