FDA Registration
Active
🇺🇸 United States
ADVANCED ENGINEERING, INC.
Reg #: 3010047203
·
FEI: 3010047203
·
Expires 2026
Products
4
Proprietary Names
9
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- ADVANCED ENGINEERING, INC.
- Registration Number
- 3010047203
- FEI Number
- 3010047203
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5299 N Mishler Rd
- City
- Huntington
- State
- IN
- ZIP
- 46750
- Country
- US
Owner / Operator
- Firm Name
- Advanced Engineering, Inc.
- Operator Number
- 10042897
- Address
- 5299 N. Mishler Rd.
- City
- Huntington
- State
- IN
- Postal Code
- 46750
- Country
- US
- Correspondent
- Frances Stouffer
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | Class 1 | Clinical Chemistry | No | 2013-01-09 |
| Supplies, Blood-Bank | KSS | Class 1 | Hematology | No | 2013-01-09 |
| Peripheral Blood Processing Device For Osteoarthritis | PZT | Class N | Unknown | No | 2017-12-14 |
| Spatula, Cervical, Cytological | HHT | Class 2 | Obstetrics/Gynecology | No | 2020-03-10 |
Proprietary Names
Biocue Platelet Conc. System
CENTRIFUGE & ACCESSORY
GPS II and Plasmax with 30ml ACD-A
GPS III - std, mini, double, kits, Plasmax w/GPS III mini, Plasmax Plus w/GPS III
GPS II Platelet Concentrate Separation Kit
Marrowstim Concentration Kits
nSTRIDE APS Kit (800-3000ST), APS Kit (800-3000JP)
Spatula
GPS II Platelet Concentrate Separation Kit w/Plasmax accessory
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Device in the United States for Export Only