| Primary Device ID | 10810143620044 |
| NIH Device Record Key | 6fbe5835-5fea-457c-a5ef-044a7c2754cf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GenaCheck Alcohol Rapid Self-Test Kit |
| Version Model Number | RA9-E01905 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810143620047 [Primary] |
| GS1 | 10810143620044 [Unit of Use] |
| DMJ | Test Reagents For Ethyl Alcohol |
| 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 |
| 00810143620344 - GenaCheck® COVID-19/Flu A&B Rapid Self-Test | 2025-05-27 GenaCheck® COVID-19/Flu A&B Rapid Self-Test 2T |
| 00810143620368 - GenaCheck® COVID-19/Flu A&B Rapid Self-Test | 2025-05-27 GenaCheck® COVID-19/Flu A&B Rapid Self-Test 4T |
| 00810143620214 - GenaCheck® FSH At-Home Menopause Test | 2025-03-06 |
| 00810143620221 - GenaCheck® Early Result Pregnancy Test | 2025-03-06 |
| 00810143620115 - GenaCheck® Nitrile Powder Free Examination Glove | 2025-01-21 |
| 00810143620139 - GenaCheck® Nitrile Powder Free Examination Glove | 2025-01-21 |
| 00810143620146 - GenaCheck® Nitrile Powder Free Examination Glove | 2025-01-21 |
| 00810143620153 - GenaCheck® Nitrile Powder Free Examination Glove | 2025-01-21 |