FDA Registration
Active
🇺🇸 United States
Sun Diagnostics, LLC
Reg #: 3009672007
·
FEI: 3009672007
·
Expires 2026
Products
5
Proprietary Names
21
Establishment Types
4
Classifications
5
Registration Details
- Registration Name
- Sun Diagnostics, LLC
- Registration Number
- 3009672007
- FEI Number
- 3009672007
- Status
- Active
- Expiry Year
- 2026
- 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 |
|---|---|---|---|---|---|
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2026-03-16 |
| Research Use Only/Immunology Devices | OTR | Class N | Unknown | No | 2015-05-07 |
| Reagents, Specific, Analyte | MVU | Class 1 | Pathology | No | 2014-04-16 |
| Multi-Analyte Controls Unassayed | OHQ | Class 1 | Clinical Chemistry | No | 2013-04-30 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2012-06-21 |
Proprietary Names
Insulated Lockbox Insert
SunDx Lp(a)-P ELISA
SunDx Rapid Biotin Assay - BTN
n/a
LP QC
GAL3 QC
TG QC
Lp(a) QC
Fibrinogen QC (FIBQC)
ProInsulin QC (PIQC)
LP-PLA2 QC
Leptin QC
MPO QC
Assurance RF Interference Test Kit
Assurance Drug Interference Test Kit
Assurance HAMA Interference Test Kit
Assurance Interference Test Kit for Urine Interferents
Assurance Interference Test Kit for Endogenous Interferents
ASSURANCE Biotin Interferent
Assurance Interference Test Kit
LipoSep IP
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198