FDA Registration
Active
🇺🇸 United States
SunDx Lp(a)-P ELISA
Reg #: 3009672007
·
FEI: 3009672007
·
Expires 2025
Products
1
Proprietary Names
2
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 |
|---|---|---|---|---|---|
| Research Use Only/Immunology Devices | OTR | Class N | Unknown | No | 2015-05-07 |
Proprietary Names
SunDx Lp(a)-P ELISA
SunDx Rapid Biotin Assay - BTN
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device