# Roche Lumira Dx Bathgate

FEI: 3039322300
Status: Active
Establishment types: Manufacture Medical Device
Owner/operator: Roche Diagnostics Operations Inc. (#9039767)

Address: 39 Inchmuir Road, Whitehill Industrial Estate, Bathgate Scotland, EH48 2EP, GB

Mandatory US Agent: ROCHE DIAGNOSTICS OPERATIONS INC.

## Products

Total registered: 1
Top product codes: QKP
Regulation §: —

Proprietary names: LumiraDx Instrument V5E (EN,US) EUA, LumiraDx SARS-CoV-2 Ag Test, LumiraDx SARS-CoV-2 Ag Quality Controls, LMDx Instrument V5E (EN,US) EUA,Serviced, LumiraDx SARS-CoV-2 Ag (48T)EUA ,EN-US, LumiraDx SARS-CoV-2 Ag Control (2pk)EUA

## Source

- openFDA: https://api.fda.gov/device/registrationlisting.json?search=registration.fei_number:%223039322300%22
- FDA Registration Lookup: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=3039322300