FDA Registration
Active
🇺🇸 United States
Leishmania infantum IgG Level 1 Serum
Reg #: 3007208259
·
FEI: 3007208259
·
Expires 2025
Products
1
Proprietary Names
8
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 |
|---|---|---|---|---|---|
| Reagents, Specific, Analyte | MVU | Class 1 | Pathology | No | 2014-12-02 |
Proprietary Names
Leishmania infantum IgG Level 1 Serum
HHV-6 IgG Sera Pack
HHV-6 IgM Sera Pack
HHV-6 IgM Plates - Bulk
HHV-6 IgG Plates - Bulk
Leishmania infantum IgG Level 3 Serum
Leishmania infantum Antigen Wells
Leishmania infantum IgG Level 2 Serum
Establishment Types
Repack or Relabel Medical Device