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Gold Standard Diagnostics, LLC

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
15
Inspections
3
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K250249Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemOctober 10, 2025
K203295Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitMarch 22, 2021
K203292Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitMarch 22, 2021
K203289Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test KitMarch 22, 2021
K203296Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitMarch 22, 2021
K200023Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitApril 6, 2020
K200025Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitApril 6, 2020
K180264Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitMay 2, 2018
K150358Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemNovember 12, 2015
K131334HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TESTFebruary 28, 2014
K131330GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KITJanuary 28, 2014
K113846BORRELIA BURGDORFERI IGM BLOT TESTJune 1, 2012
K113847BORRELIA BURGDORFERI IGG BLOT TESTApril 11, 2012
K110745HELICOBACTER PYLORI ELISA IGG TEST KITMarch 2, 2012
K110899GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KITFebruary 1, 2012