FDA Device Establishments · JSON-LD · Markdown

Roche Lumira Dx Stirling

FEI 3039321686 · Manufacture Medical Device · Status: Active

FEI Number3039321686
Owner / OperatorRoche Diagnostics Operations Inc. (#9039767)
AddressManor Farm Business Park, Manor Loan Stirling, FK9 5QD, 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).