FDA Device Establishments · JSON-LD · Markdown

Roche Lumira Dx Bathgate

FEI 3039322300 · Manufacture Medical Device · Status: Active

FEI Number3039322300
Owner / OperatorRoche Diagnostics Operations Inc. (#9039767)
Address39 Inchmuir Road, Whitehill Industrial Estate, Bathgate Scotland, EH48 2EP, GB
Mandatory US AgentROCHE DIAGNOSTICS OPERATIONS INC.
Registration expiry2026
Initial importer flagN
Registered products1
Product codes (top 20)QKP
Proprietary namesLumiraDx 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

External sources

Source: openFDA. Public-domain (CC0).