Manufacturer's Devices - BioFire Diagnostics LLC

Address:




515 Colorow Drive Salt Lake City



Utah

Salt Lake City UT84108

United States


Authorised Representative/ UK Responsible Person
Name: bioMérieux UK Ltd
Address:

Chineham Gate Crockford Lane



Basingstoke

Hampshire RG24 8NA

England United Kingdom




Code/Term Type
Multiple-type meningitis pathogen nucleic acid IVD kit nucleic acid technique (NAT)Multiple-type meningitis pathogen nucleic acid IVD kit nucleic acid technique (NAT)IVD Annex II List B
Multiple-type respiratory pathogen nucleic acid IVD kit nucleic acid technique (NAT)Multiple-type respiratory pathogen nucleic acid IVD kit nucleic acid technique (NAT)IVD Annex II List B
Multiple-type gastrointestinal pathogen nucleic acid IVD kit nucleic acid technique (NAT)Multiple-type gastrointestinal pathogen 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
Thermal cycler nucleic acid amplification analyser IVD laboratoryThermal cycler nucleic acid amplification analyser IVD laboratoryIVD General
Multiple-type osteoarticular pathogen nucleic acid IVD kit nucleic acid technique (NAT)Multiple-type osteoarticular pathogen nucleic acid IVD kit nucleic acid technique (NAT)IVD General