← Product Code [QYT](/submissions/MI/subpart-d%E2%80%94serological-reagents/QYT) · K260095

# Heal-Check Rapid COVID-19 Antigen Self-Test (K260095)

_Healgen Scientific,, LLC · QYT · Apr 13, 2026 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QYT/K260095

## Device Facts

- **Applicant:** Healgen Scientific,, LLC
- **Product Code:** [QYT](/submissions/MI/subpart-d%E2%80%94serological-reagents/QYT.md)
- **Decision Date:** Apr 13, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3984
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Regulatory Identification

For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QYT/K260095](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QYT/K260095)

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