Certificates: CE, ISO, MDL & GMP

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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.

CAN/CSA ISO 13485:2003 certificate

CAN/CSA ISO 13485:2003 addendum

The scope of the certification entails the design and development and administration services related to Nuclei Acid Based In Vitro Diagnostic Medical Devices (including software).

This certification also includes the location(s) as identified on the addendum belonging to this certificate.

 CE Certificate

CE-IVD Certificate No V2 102580 0001 Rev.2

Declarations of conformity

GenDx AlleleSEQR® HLA-C, DPB1 and DQB1

GenDx AlleleSEQR® HLA-A, B and DRB


NGSengine® EC, IVDD 98/78/EC

NGSgo® workflow compatible with Illumina, IVD 98/79/EC

NGSgo®-AmpX, IVD 98/79

NGSgo®-AmpX v2 IVD 98/79

NGSgo®-MX6-1 IVD 98/79


SBTengine®, IVDD 98/79/EC 

SBTexcellerator® HLA-A, B and DRB, IVD 98/79

SBTexcellerator® HLA-C, DQB1, DQA1, DPB1 and DPA1, IVD 98/79


KMRtype®, KMRtrack®, KMRassayTM IVD 98/79/EC

KMRengine®, IVD 98/79/EC

 

GMP Certificate

Korean GMP certificate – GenDx

Health Canada – Medical Device Licenses

MDL – AlleleSEQR

MDL – NGSengine