Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of EurofinsLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Gold Standard Diagnostics with 15 510(k) clearances. The most recent is a 510(k) clearance dated Oct 10, 2025: Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 10, 2025 | Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemK250249 · GMQ | 510(k) clearances |
| Mar 22, 2021 | Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitK203292 · LSR | 510(k) clearances |
| Mar 22, 2021 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitK203295 · LSR | 510(k) clearances |
| Mar 22, 2021 | Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test KitK203289 · LSR | 510(k) clearances |
| Mar 22, 2021 | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitK203296 · LSR | 510(k) clearances |
| Apr 6, 2020 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitK200023 · LSR | 510(k) clearances |
| Apr 6, 2020 | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitK200025 · LSR | 510(k) clearances |
| May 2, 2018 | Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitK180264 · LSR | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
