Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3039321686

FEI Number

3039321686

Entity Name

Roche Lumira Dx Stirling

City/State/Country

Manor Loan Stirling, GB

Establishment Address

Manor Farm Business Park, Manor Loan Stirling FK9 5QD, 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

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
3039322300	Roche Lumira Dx Bathgate	Bathgate Scotland, 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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9610126	ROCHE DIAGNOSTICS GMBH	MANNHEIM Baden-Wurttemberg, DE
3008054239	CORE TECHNOLOGY CO., LTD.	Changping District Beijing, CN
3016761091	Shenzhen Watmind Medical Co., Ltd.	Shenzhen Guangdong, CN
3002642396	Ortho Clinical Diagnostics	Singapore South West, SG

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3039321686. Last updated year: 2026. Please use registration number 3039321686 when referencing this establishment in official correspondence.