FebriDx® Bacterial / Non-Bacterial Point of Care Assay

Basic Information

• Brand Name: FebriDx® Bacterial / Non-Bacterial Point of Care Assay
• Primary DI: 00850056728102
• Version / Model: CP0014
• Catalog Number: CP0014
• Company Name: Lumos Diagnostics, Inc.
• Labeler DUNS: 081135788
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-21
• Public Version: 1
• Public Version Date: 2023-12-29
• Public Version Status: New
• Public Device Record Key: a1ea6133-1542-42e8-814b-0d212c696245

Device Description

FebriDx® Bacterial / Non-Bacterial Point of Care Assay Test Kit, 25 tests

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QXA	Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection	Microbiology	866.3230	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850056728102	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K230917	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 25 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 5 – 85 Percent (%) Relative Humidity