AccessGUDID - DEVICE: FebriDx® Bacterial / Non-Bacterial Assay (00850056728126)

GUDID

Device Identifier (DI) Information

Brand Name: FebriDx® Bacterial / Non-Bacterial Assay
Version or Model: CP0014
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CP0014
Company Name: Lumos Diagnostics, Inc.

Primary DI Number: 00850056728126
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081135788 *Terms of Use

Device Description: FebriDx® Bacterial / Non-Bacterial Assay Test Kit, 25 tests

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64042	Multiple cell-mediated host immune response marker IVD, kit, rapid ICT, clinical	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QXA	Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K260787	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 4 and 25 Degrees Celsius
Handling Environment Humidity: between 5 and 85 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 855ebf4a-a959-4fd1-b1ba-0652319cd4c3
Public Version Date: May 05, 2026
Public Version Number: 1
DI Record Publish Date: April 27, 2026