EU Manufacturer
๐บ๐ธ United States
Active
Gold Standard Diagnostics, LLC
SRN: US-MF-000027142
ยท
2nd Street 2795, 95618 Davis, CA, United States
Basic UDI-DIs
10
Total Devices
10
On Market
10
Off Market
0
Certificates
0
Valid
0
Expiring < 6mo
0
Countries
12
Basic Information
- Address
- 2nd Street 2795, 95618 Davis, CA, United States
- [email protected]
- Phone
- +1 530 759 8000
- Website
- https://www.gsdx.us/
Regulatory Overview
Regulation
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Eu Ivdd
5
Eu Ivdr
5
Classification
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Eu Ivd Class A
5
Eu Ivd General
5
Device Types
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Certificate Health
No certificates registered for this manufacturer.
Market Presence
Devices from this manufacturer are available in 12 countries across Europe.
๐ฆ๐น Austria
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ช๐ธ Spain
๐ซ๐ท France
๐ฎ๐ช Ireland
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐บ Luxembourg
๐ฒ๐น Malta
๐ต๐น Portugal
๐ธ๐ฎ Slovenia
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| AIX1000 Analyzer | EU IVDD | Eu Ivd General | On Market | 0 |
| Bolt | EU IVDR | Eu Ivd Class A | On Market | 0 |
| Bolt (CLIA) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| Gold Standard Diagnostics RPR Reagent Pack | EU IVDD | Eu Ivd General | On Market | 0 |
| Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System | EU IVDD | Eu Ivd General | On Market | 0 |
| Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System-5C | EU IVDD | Eu Ivd General | On Market | 0 |
| HAILSTORM | EU IVDR | Eu Ivd Class A | On Market | 0 |
| Microtiterplates | EU IVDD | Eu Ivd General | On Market | 0 |
| ThunderBolt EIA | EU IVDR | Eu Ivd Class A | On Market | 0 |
| ThunderBolt EIA (CLIA) | EU IVDR | Eu Ivd Class A | On Market | 0 |