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Gold Standard Diagnostics

14 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit (K203295)Gold Standard Diagnostics2021-03-22
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit (K203292)Gold Standard Diagnostics2021-03-22
Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit (K203296)Gold Standard Diagnostics2021-03-22
Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit (K203289)Gold Standard Diagnostics2021-03-22
Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit (K200023)Gold Standard Diagnostics2020-04-06
Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit (K200025)Gold Standard Diagnostics2020-04-06
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit (K180264)Gold Standard Diagnostics2018-05-02
Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System (K150358)Gold Standard Diagnostics2015-11-12
HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST (K131334)Gold Standard Diagnostics2014-02-28
GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT (K131330)Gold Standard Diagnostics2014-01-28
BORRELIA BURGDORFERI IGM BLOT TEST (K113846)Gold Standard Diagnostics2012-06-01
BORRELIA BURGDORFERI IGG BLOT TEST (K113847)Gold Standard Diagnostics2012-04-11
HELICOBACTER PYLORI ELISA IGG TEST KIT (K110745)Gold Standard Diagnostics2012-03-02
GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT (K110899)Gold Standard Diagnostics2012-02-01

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Every clearance here is in the API, with alerts when new ones post.