Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test
Device Facts
| Record ID | K260754 |
|---|---|
| Device Name | Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test |
| Applicant | Assure Tech., LLC |
| Product Code | QYT · Microbiology |
| Decision Date | Jun 5, 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.
