| Primary Device ID | 00810143620030 |
| NIH Device Record Key | 1beaf47d-4fb0-4bc6-9a18-902b434948be |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GenaCheck Rapid Self-Test Kit For Cannabis |
| Version Model Number | RA9-E02005 |
| Company DUNS | 118586095 |
| Company Name | Genabio Diagnostics Inc. |
| Device Count | 5 |
| 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 |