ViraDx™ SARS-CoV-2/Flu A+B Rapid Antigen Test CP0031
GUDID 00850056728706
ViraDx™ SARS-CoV-2/Flu A+B Rapid Antigen Test Kit, 25 tests
Lumos Diagnostics, Inc.
SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical| Primary Device ID | 00850056728706 |
| NIH Device Record Key | 2767cbe2-93f7-47d4-bb6c-e350ae127d59 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ViraDx™ SARS-CoV-2/Flu A+B Rapid Antigen Test |
| Version Model Number | CP0031 |
| Catalog Number | CP0031 |
| 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 | |
| Phone | 1-855-586-6739 |
| info@lumosdiagnostics.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850056728706 [Primary] |
FDA Product Code
| QKP | Coronavirus Antigen Detection Test System. |
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 | 2023-12-08 |
| Device Publish Date | 2023-11-30 |
Devices Manufactured by Lumos Diagnostics, Inc.
| 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 | 2023-12-08ViraDx™ SARS-CoV-2/Flu A+B Rapid Antigen Test Kit, 25 tests |
| 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 [ViraDx]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VIRADX 97278404 not registered Live/Pending |
Rapid Pathogen Screening, Inc. 2022-02-22 |
 VIRADX 77562860 3653714 Dead/Cancelled |
PLANTIVA, LLC 2008-09-04 |
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