FDA.reportPublic FDA data

FebriDx® Bacterial / Non-Bacterial Assay

Primary DI
00850056728119
Brand
FebriDx® Bacterial / Non-Bacterial Assay
Company
Lumos Diagnostics, Inc.
Model
CP0517
Catalog number
CP0517
Device description
INDICAID branding of FebriDx® Bacterial / Non-Bacterial Assay Test Kit, 25 tests
Published
2026-04-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QXALateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QXALateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory InfectionMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260787000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260787000FebriDx Bacterial/Non-bacterial AssayLumos Diagnostics, Inc.2026-03-24QXA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850056728119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850056728119008500567281198500567281190850056728119

GMDN Terms#

Term, Definition table
TermDefinition
Multiple cell-mediated host immune response marker IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple cell-mediated (i.e., non-immunoglobulin) host immune response markers of bacterial and/or viral infection in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses to differentiate bacterial from viral infection, and/or to predict patient outcomes by grading disease severity. It is not intended to be used for self-testing.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity5 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-855-586-6739info@lumosdiagnostics.com

Regulatory Flags#

DUNS number
081135788
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850056728126FebriDx® Bacterial / Non-Bacterial AssayCP0014CP00142026-04-27
00850056728102FebriDx® Bacterial / Non-Bacterial Point of Care AssayCP0014CP00142023-12-21
00850056728706ViraDx™ SARS-CoV-2/Flu A+B Rapid Antigen TestCP0031CP00312023-11-30
00850056728409FebriDx® Bacterial / Non-Bacterial Point of Care Assay, External Controls KitCP0007CP00072023-12-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850056728126FebriDx® Bacterial / Non-Bacterial AssayLumos Diagnostics, Inc.QXA2026-04-27
00850056728102FebriDx® Bacterial / Non-Bacterial Point of Care AssayLumos Diagnostics, Inc.QXA2023-12-21