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Sign in to claim this brandGold Standard Diagnostics, LLC
United States·US-MF-000027142
Last updated September 17, 2026
About
Gold Standard Diagnostics, LLC. is a leading healthcare provider of diagnostic solutions with extensive experience in the clinical market. Our comprehensive diagnostic offering includes an innovative suite of automated platforms and a broad menu of assays, completed with outstanding customer service. We aim to provide solutions that improve lab efficiency and minimize overall costs.
From the manufacturer's own website. Source
Information
- Country
- United States
- Address
- 2795, 2nd Street, Davis, CA, United States
- Website
- www.gsdx.us/
- —
- —
- [email protected]
- Phone
- +15123128413
- PRRC Contact
- Tony Sanford
- EUDAMED SRN
- US-MF-000027142
- FDA FEI Number
- 3007208259
- DUNS Number
- —
Catalogue (107)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Hailstorm | 00350 | EUDAMED | Class A | Active |
| Bolt (CLIA) | 00500-CL | EUDAMEDFDA UDI | Class A | Active |
| ThunderBolt EIA (CLIA) | 00300-CL | EUDAMEDFDA UDI | Class A | Active |
| Bolt | 00500 | EUDAMEDFDA UDI | Class A | Active |
| Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System-5C | GSD01-1600-5C | EUDAMEDFDA UDI | IVD General | Active |
| Microtiterplates | GSD-1600-W-CASE | EUDAMEDFDA UDI | IVD General | Active |
| Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System | GSD01-1600 | EUDAMEDFDA UDI | IVD General | Active |
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