FDA.reportPublic FDA data

Lumos Diagnostics, Inc.

Matched from indexed company URL: LUMOS, INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30066022093006602209Lumos Diagnostics, Inc.1N2026-01-012724 Loker Avenue Carlsbad CA US 92010

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850056728102FebriDx® Bacterial / Non-Bacterial Point of Care Assay - FebriDx® Bacterial / Non-Bacterial Point of Care Assay Test Kit, 25 tests1-855-586-6739info@lumosdiagnostics.com
00850056728119FebriDx® Bacterial / Non-Bacterial Assay - INDICAID branding of FebriDx® Bacterial / Non-Bacterial Assay Test Kit, 25 tests1-855-586-6739info@lumosdiagnostics.com
00850056728126FebriDx® Bacterial / Non-Bacterial Assay - FebriDx® Bacterial / Non-Bacterial Assay Test Kit, 25 tests1-855-586-6739info@lumosdiagnostics.com
00850056728409FebriDx® Bacterial / Non-Bacterial Point of Care Assay, External Controls Kit - CP00071-855-586-6739info@lumosdiagnostics.com
00850056728706ViraDx™ SARS-CoV-2/Flu A+B Rapid Antigen Test - ViraDx™ SARS-CoV-2/Flu A+B Rapid Antigen Test Kit, 25 tests1-855-586-6739info@lumosdiagnostics.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
847171094840917K260787FebriDx Bacterial/Non-bacterial AssayQXA2026-03-24
847171813235940K230917FebriDx Bacterial / Non-bacterial Point of Care AssayQXA2023-06-30
847171887310324
847171864584702
847171971595077

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QXA22026-03-24

PMN#

GUDID#