FDA Registration
Active
🇺🇸 United States
AIVITA BIOMEDICAL, INC.
Reg #: 3013221738
·
FEI: 3013221738
·
Expires 2026
Products
8
Proprietary Names
2
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- AIVITA BIOMEDICAL, INC.
- Registration Number
- 3013221738
- FEI Number
- 3013221738
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 18301 Von Karman Ave, Suite 130
- City
- Irvine
- State
- CA
- ZIP
- 92612
- Country
- US
Owner / Operator
- Firm Name
- AIVITA Biomedical, Inc.
- Operator Number
- 10089030
- Address
- 18301 Von Karman Ave, Suite 130
- City
- Irvine
- State
- CA
- Postal Code
- 92612
- Country
- US
- Correspondent
- Rockelle Robles
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2023-11-09 |
| Container, Liquid Medication, Graduated | KYW | Class 1 | General Hospital | No | 2023-11-09 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2023-11-09 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2023-11-09 |
| Media And Components, Synthetic Cell And Tissue Culture | KIT | Class 1 | Hematology | No | 2023-11-09 |
| Lymphocyte Separation Medium | JCF | Class 1 | Hematology | No | 2023-11-09 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2023-11-09 |
| System, Suspension, Cell Culture | KJF | Class 1 | Hematology | No | 2023-11-09 |
Proprietary Names
MyOwnVaccine
Clean Super Vaccine
Establishment Types
Manufacture Device in the United States for Export Only