| Primary Device ID | 00860001286533 |
| NIH Device Record Key | d106a9aa-84fd-4464-a5cb-e53da07b8d7f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Men's Rapid Fertility Test |
| Version Model Number | TQK-0-1 |
| 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 |