FDA Registration
Active
🇺🇸 United States
Bolt (CLIA)
Reg #: 3007208259
·
FEI: 3007208259
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GOLD STANDARD DIAGNOSTICS, LLC
- Registration Number
- 3007208259
- FEI Number
- 3007208259
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2795 2nd St Ste 300
- City
- Davis
- State
- CA
- ZIP
- 95618
- Country
- US
Owner / Operator
- Firm Name
- Gold Standard Diagnostics
- Operator Number
- 10025460
- Address
- 2795 2nd Street, Suite 300
- City
- Davis
- State
- CA
- Postal Code
- 95618
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2012-05-18 |
Proprietary Names
Bolt (CLIA)
Performance Check Dye Kit
Thunderbolt EIA (CLIA)
Thunderbolt EIA
Bolt
Establishment Types
Manufacture Medical Device