Manufacturer's Devices - GenMark Diagnostics

Address:




5964 La Place Ct



CARLSBAD

California 92008

United States


Authorised Representative/ UK Responsible Person
Name: Emergo Consulting (UK) Limited
Address:

Compass House Vision Park Histon c/o Cr360 – UL International



Cambridge

CB24 9BZ

England United Kingdom




Code/Term Type
Multiple respiratory virus nucleic acid IVD kit nucleic acid technique (NAT)Multiple respiratory virus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Multiple-type bloodstream pathogen nucleic acid IVD kit nucleic acid amplification/mass spectrometryMultiple-type bloodstream pathogen nucleic acid IVD kit nucleic acid amplification/mass spectrometryIVD General
Nucleic acid sequence analyser IVD next-generation sequencing (NGS)Nucleic acid sequence analyser IVD next-generation sequencing (NGS)IVD General
Multiple respiratory virus antigen IVD kit multiplexMultiple respiratory virus antigen IVD kit multiplex Conformity Assessment Certificate ExpiredIVD Annex II List B