FDA Registration
Active
🇺🇸 United States
LipoSep IP
Reg #: 3009672007
·
FEI: 3009672007
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Sun Diagnostics, LLC
- Registration Number
- 3009672007
- FEI Number
- 3009672007
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 60 Pineland Drive, Brunswick Hall, Suite 322
- City
- New Gloucester
- State
- ME
- ZIP
- 04260
- Country
- US
Owner / Operator
- Firm Name
- Sun Diagnostics, LLC
- Operator Number
- 10041112
- Address
- 60 Pineland Drive, Brunswick Hall, Suite 322
- City
- New Gloucester
- State
- ME
- Postal Code
- 04260
- Country
- US
- Correspondent
- Rae-Anne Nguyen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2012-06-21 |
Proprietary Names
LipoSep IP
Assurance Drug Interference Test Kit
Assurance RF Interference Test Kit
Assurance Interference Test Kit for Endogenous Interferents
Assurance Interference Test Kit for Urine Interferents
Assurance HAMA Interference Test Kit
ASSURANCE Biotin Interferent
Assurance Interference Test Kit
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device