| Primary Device ID | 00862105000312 |
| NIH Device Record Key | 84a27955-deff-40bf-a120-01df8a79b26c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Men's Rapid Fertility Test |
| Version Model Number | TRK-0-1 Rev 4 |
| Company DUNS | 118569262 |
| Company Name | MEDTOX 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 | false |
| 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 |