Heal-Check Rapid COVID-19 Antigen Self-Test
Device Facts
| Record ID | K260095 |
|---|---|
| Device Name | Heal-Check Rapid COVID-19 Antigen Self-Test |
| Applicant | Healgen Scientific,, LLC |
| Product Code | QYT · Microbiology |
| Decision Date | Apr 13, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3984 |
| Device Class | Class 2 |
Regulatory Classification
Identification
For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older.
