| Primary Device ID | 30810172700094 |
| NIH Device Record Key | f7f04914-b54e-4ed1-8984-4c16904a05a4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CARTON-RDB1V10-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Test (1 Test/Box) |
| Version Model Number | CARTON-RDB1V10-BIO-Speedy Swab Rapid COVID-19 & FL |
| Company DUNS | 117617770 |
| Company Name | WatMIND USA |
| 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 | false |
| 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 |