Roche Lumira Dx Bathgate

FDA Device Registration & Listing · Bathgate Scotland, GB · Registration 3039322300

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3039322300
FEI Number
3039322300
Entity Name
Roche Lumira Dx Bathgate
City/State/Country
Bathgate Scotland, GB
Establishment Address
39 Inchmuir Road, Whitehill Industrial Estate, Bathgate Scotland EH48 2EP, GB
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Roche Diagnostics Operations Inc. (Owner Number: 9039767)
Owner / Operator Contact Address
9115 Hague Road, Indianapolis, IN 46250, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QKP Coronavirus Antigen Detection Test System. Unknown Class N N/A 2020-12-07

Official Correspondent

No official correspondent registered.

US Agent Details

Brian Frazier Business: ROCHE DIAGNOSTICS OPERATIONS INC. Email: brian.frazier@roche.com Phone: (317) 3194485

Related Public Records

Same Entity

Roche Diagnostics Operations Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3010900203 Roche Diagnostics S.L. Sant Cugat del Valles Barcelona, ES
3039321686 Roche Lumira Dx Stirling Manor Loan Stirling, GB
3011806823 Roche Diabetes Care GmbH Mannheim Baden-Wurttemberg, DE
3020917535 Roche Diagnostics (Suzhou) Ltd. Suzhou Jiangsu, CN
3011393376 ROCHE DIABETES CARE, INC. Indianapolis, IN, US

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2023 Jiangsu Well Biotech Co., Ltd. No N
Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3039322300. Last updated year: 2026. Please use registration number 3039322300 when referencing this establishment in official correspondence.
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