Gold Standard Diagnostics
FDA 510(k) medical device clearances.
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.