| Primary Device ID | 00197644204359 |
| NIH Device Record Key | 0a9e0909-a79a-413e-af09-53f0e9babfbc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bio-Self COVID-19 Antigen Home Test |
| Version Model Number | BTK-H2205 |
| Company DUNS | 111149202 |
| Company Name | BIOTEKE USA, LLC |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| 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 | 00197644204359 [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 | 2025-01-23 |
| Device Publish Date | 2025-01-15 |
| 00197644563371 | COVID-19 antigen self home test in vitro diagnostic use only (1 Test Kit/Box) |
| 00197644380435 | COVID-19 antigen self home test in vitro diagnostic use only (2 Test Kits/Box) |
| 00197644204359 | COVID-19 antigen self home test in vitro diagnostic use only (5 Test Kits/Box) |
| 00860013635121 | COVID-19 antigen self home test in vitro diagnostic use only (5 Test Kits/Box) |
| 00860013635114 | COVID-19 antigen self home test in vitro diagnostic use only (2 Test Kits/Box) |
| 00860013635107 | COVID-19 antigen self home test in vitro diagnostic use only (1 Test Kit/Box) |