| Primary Device ID | 00810143620092 |
| NIH Device Record Key | 2c0cc2f9-b55e-434d-bc39-26595627bee0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GenaCheck COVID-19 / Flu Rapid Self-Test Kit |
| Version Model Number | RA9-E02501 |
| Company DUNS | 118586095 |
| Company Name | Genabio Diagnostics Inc. |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810143620092 [Primary] |
| QKP | Coronavirus Antigen Detection Test System. |
| 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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