FDA device listing
Healgen COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab)
FDA device listing 1917670082 · HEALGEN SCIENTIFIC LLC
Key facts
| Proprietary names | Healgen COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) |
|---|---|
| Owner/operator | HEALGEN SCIENTIFIC LLC |
| Owner/operator number | 10038461 |
| Product codes | QMN |
| Device names | QMN - Covid-19 Multi-Analyte Antigen Device |
| Device class | Not classified |
| Classification regulations (21 CFR) | ORCA1.QMN |
| Review panels | Microbiology |
| Registered establishments | HEALGEN SCIENTIFIC LLC |
| Establishment registrations | 3009238284 |
| FEI numbers | 3009238284 |
| Establishment operations | Complaint File Establishment, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database