| Primary Device ID | 10810143620006 |
| NIH Device Record Key | 787c5ee9-39f6-4678-a622-d7ff3f901c21 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GenaCheck Rapid Self-Test Kit For Urinary Tract Infections |
| Version Model Number | RA9-E01802 |
| Company DUNS | 118586095 |
| Company Name | Genabio Diagnostics Inc. |
| Device Count | 2 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810143620009 [Primary] |
| GS1 | 10810143620006 [Unit of Use] |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-16 |
| Device Publish Date | 2023-10-06 |
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