Gold Standard Diagnostics
Gold Standard Diagnostics holds FDA 510(k) medical device clearances, first cleared 2012, most recent 2021.
Top product codes for Gold Standard Diagnostics
Recent clearances by Gold Standard Diagnostics
- K203289 — Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit
- K203292 — Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
- K203295 — Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
- K203296 — Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
- K200023 — Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
- K200025 — Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
- K180264 — Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
- K150358 — Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
- K131334 — HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST
- K131330 — GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT
- K113846 — BORRELIA BURGDORFERI IGM BLOT TEST
- K113847 — BORRELIA BURGDORFERI IGG BLOT TEST
- K110745 — HELICOBACTER PYLORI ELISA IGG TEST KIT
- K110899 — GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.