| Primary Device ID | 06921963712493 |
| NIH Device Record Key | 92468d11-679c-4be7-998c-a3bc278867dd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Boson - Rapid SARS-CoV-2 Antigen Test Card - 1 Tests/Kit |
| Version Model Number | 1N40C5-1-US |
| Company DUNS | 527409818 |
| Company Name | Xiamen Boson Biotech Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| OTC Over-The-Counter | true |
| Phone | +1-800-689-7794 |
| support@bosoncovt.com | |
| Phone | +1-800-689-7794 |
| support@bosoncovt.com | |
| Phone | +1-800-689-7794 |
| support@bosoncovt.com | |
| Phone | +1-800-689-7794 |
| support@bosoncovt.com | |
| Phone | +1-800-689-7794 |
| support@bosoncovt.com | |
| Phone | +1-800-689-7794 |
| support@bosoncovt.com | |
| Phone | +1-800-689-7794 |
| support@bosoncovt.com | |
| Phone | +1-800-689-7794 |
| support@bosoncovt.com | |
| Phone | +1-800-689-7794 |
| support@bosoncovt.com | |
| Phone | +1-800-689-7794 |
| support@bosoncovt.com | |
| Phone | +1-800-689-7794 |
| support@bosoncovt.com | |
| Phone | +1-800-689-7794 |
| support@bosoncovt.com | |
| Phone | +1-800-689-7794 |
| support@bosoncovt.com | |
| Phone | +1-800-689-7794 |
| support@bosoncovt.com | |
| Phone | +1-800-689-7794 |
| support@bosoncovt.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06921963712493 [Primary] |
| GS1 | 16921963712490 [Package] Package: Case [12 Units] In Commercial Distribution |
| QKP | Coronavirus Antigen Detection Test System. |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-17 |
| Device Publish Date | 2022-10-08 |
| 06921963712493 - Boson - Rapid SARS-CoV-2 Antigen Test Card - 1 Tests/Kit | 2022-10-17Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19. |
| 06921963712493 - Boson - Rapid SARS-CoV-2 Antigen Test Card - 1 Tests/Kit | 2022-10-17 Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with sym |
| 06921963712509 - Boson - Rapid SARS-CoV-2 Antigen Test Card - 2 Tests/Kit | 2022-10-03 Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with sym |
| 06921963715258 - Boson - Rapid SARS-CoV-2 Antigen Test Card - 8 Tests/Kit | 2022-10-03 Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with sym |