FDA device listing
Clean Super Vaccine,MyOwnVaccine
FDA device listing 1984772134 · AIVITA Biomedical, Inc.
Key facts
| Proprietary names | Clean Super Vaccine,MyOwnVaccine |
|---|---|
| Owner/operator | AIVITA Biomedical, Inc. |
| Owner/operator number | 10089030 |
| Product codes | JKA |
| Device names | JKA - Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1675 |
| Review panels | Clinical Chemistry |
| Registered establishments | AIVITA BIOMEDICAL, INC. |
| Establishment registrations | 3013221738 |
| FEI numbers | 3013221738 |
| Establishment operations | U.S. Manufacturer of Export Only Devices |
| 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