FDA device listing
Gold Standard Diagnostics Is-EBV-VCA IgM Test Kit
FDA device listing 1378876817 · Gold Standard Diagnostics
Key facts
| Proprietary names | Gold Standard Diagnostics Is-EBV-VCA IgM Test Kit |
|---|---|
| Owner/operator | Gold Standard Diagnostics |
| Owner/operator number | 10025460 |
| Premarket submissions | K982352 |
| Product codes | LSE |
| Device names | LSE - Epstein-Barr Virus, Other |
| Device class | Class I |
| Classification regulations (21 CFR) | 866.3235 |
| Review panels | Microbiology |
| Registered establishments | GOLD STANDARD DIAGNOSTICS, LLC |
| Establishment registrations | 3007208259 |
| FEI numbers | 3007208259 |
| Establishment operations | Repackager/Relabeler, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database