| Primary Device ID | 00810172700048 |
| NIH Device Record Key | 948610c8-d047-44ca-b407-b00c45cfdeca |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 25 Tests/Box |
| Version Model Number | SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-T |
| 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 |