| Primary Device ID | 30014613340188 |
| NIH Device Record Key | 0ac9cba0-4b64-48a5-8f0f-e7fda5dc4296 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CVS Health At Home COVID-19 Test Kit |
| Version Model Number | 20452 |
| Catalog Number | 289586 |
| Company DUNS | 117359612 |
| Company Name | DIAGNOSTIC HYBRIDS, 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | 30014613340188 [Primary] |
| QYT | Over-the-Counter COVID-19 Antigen Test |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-28 |
| Device Publish Date | 2024-11-20 |
| 30014613340188 | QuickVue COVID-19 Test |
| 00050428101735 | CVS Health At Home COVID-19 Test Kit |