FebriDx® Bacterial / Non-Bacterial Point of Care Assay CP0014
GUDID 00850056728102
FebriDx® Bacterial / Non-Bacterial Point of Care Assay Test Kit, 25 tests
Lumos Diagnostics, Inc.
Multiple cell-mediated host immune response marker IVD, kit, rapid ICT, clinical| Primary Device ID | 00850056728102 |
| NIH Device Record Key | a1ea6133-1542-42e8-814b-0d212c696245 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FebriDx® Bacterial / Non-Bacterial Point of Care Assay |
| Version Model Number | CP0014 |
| Catalog Number | CP0014 |
| Company DUNS | 081135788 |
| Company Name | Lumos Diagnostics, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-855-586-6739 |
| info@lumosdiagnostics.com | |
| Phone | 1-855-586-6739 |
| info@lumosdiagnostics.com | |
| Phone | 1-855-586-6739 |
| info@lumosdiagnostics.com | |
| Phone | 1-855-586-6739 |
| info@lumosdiagnostics.com | |
| Phone | 1-855-586-6739 |
| info@lumosdiagnostics.com | |
| Phone | 1-855-586-6739 |
| info@lumosdiagnostics.com | |
| Phone | 1-855-586-6739 |
| info@lumosdiagnostics.com | |
| Phone | 1-855-586-6739 |
| info@lumosdiagnostics.com | |
| Phone | 1-855-586-6739 |
| info@lumosdiagnostics.com | |
| Phone | 1-855-586-6739 |
| info@lumosdiagnostics.com | |
| Phone | 1-855-586-6739 |
| info@lumosdiagnostics.com | |
| Phone | 1-855-586-6739 |
| info@lumosdiagnostics.com | |
| Phone | 1-855-586-6739 |
| info@lumosdiagnostics.com | |
| Phone | 1-855-586-6739 |
| info@lumosdiagnostics.com | |
| Phone | 1-855-586-6739 |
| info@lumosdiagnostics.com | |
| Phone | 1-855-586-6739 |
| info@lumosdiagnostics.com | |
| Phone | 1-855-586-6739 |
| info@lumosdiagnostics.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850056728102 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K230917
FDA Product Code
| QXA | Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-29 |
| Device Publish Date | 2023-12-21 |
Devices Manufactured by Lumos Diagnostics, Inc.
| 00850056728102 - FebriDx® Bacterial / Non-Bacterial Point of Care Assay | 2023-12-29FebriDx® Bacterial / Non-Bacterial Point of Care Assay Test Kit, 25 tests |
| 00850056728102 - FebriDx® Bacterial / Non-Bacterial Point of Care Assay | 2023-12-29 FebriDx® Bacterial / Non-Bacterial Point of Care Assay Test Kit, 25 tests |
| 00850056728409 - FebriDx® Bacterial / Non-Bacterial Point of Care Assay, External Controls Kit | 2023-12-29 FebriDx® Bacterial / Non-Bacterial Point of Care Assay, External Controls Kit |
| 00850056728706 - ViraDx™ SARS-CoV-2/Flu A+B Rapid Antigen Test | 2023-12-08 ViraDx™ SARS-CoV-2/Flu A+B Rapid Antigen Test Kit, 25 tests |
Trademark Results [FebriDx]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FEBRIDX 85839245 4837134 Live/Registered |
Rapid Pathogen Screening, Inc. 2013-02-02 |
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