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Gold Standard Diagnostics, LLC

United States·US-MF-000027142

Last updated September 17, 2026

About

Gold Standard Diagnostics, LLC. is a leading healthcare provider of diagnostic solutions with extensive experience in the clinical market. Our comprehensive diagnostic offering includes an innovative suite of automated platforms and a broad menu of assays, completed with outstanding customer service. We aim to provide solutions that improve lab efficiency and minimize overall costs.

From the manufacturer's own website. Source

Information

Country: United States
Address: 2795, 2nd Street, Davis, CA, United States
Website: www.gsdx.us/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +15123128413
PRRC Contact: Tony Sanford
EUDAMED SRN: US-MF-000027142
FDA FEI Number: 3007208259
DUNS Number: —

Catalogue (107)

Page 2 of 3

Device	Model / Reference	Registries	Class	Status
Gold Standard Diagnostics Borrelia burgdorferi VIsE-OspC ELISA IgG/ IgM Test Kit	GSD01-1027	FDA UDI	Class II	Active
Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit	GSD06-1018	FDA UDI	Class II	Unknown
Gold Standard Diagnostics Is-anti-Scl-70 ELISA Test Kit	720-280	FDA UDI	Class II	Active
RPR Reactive Control	GSD05-1600-PC	FDA UDI	Class II	Active
Gold Standard Diagnostics Is-Rheumatoid Factor ELISA Test Kit	720-710	FDA UDI	Class II	Active
Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit - Bulk	GSD04-1023	FDA UDI	Class II	Unknown
HHV-6 IgM Plates - Bulk	GSD05-1701-AW	FDA UDI	Class I	Active
Gold Standard Diagnostics Is-anti-Jo-1 ELISA Test Kit	720-290	FDA UDI	Class II	Active
SARS-CoV-2 Component Pack	GSD01-1029-CP	FDA UDI	Class I	Unknown
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit	GSD01-1031	FDA UDI	Class II	Active
HHV-6 IgG Plates - Bulk	GSD05-1700-AW	FDA UDI	Class I	Active
Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit	GSD01-1026	FDA UDI	Class II	Active
Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit	GSD01-1023	FDA UDI	Class II	Active
H. pylori IgM Sera Pack	GSD01-1002-CP	FDA UDI	Class I	Unknown
Entamoeba histolytica IgG ELISA Test Kit	GSD01-3013	FDA UDI	Class II	Active
Leishmania infantum IgG Level 2 Serum	GSD01-3006-L2	FDA UDI	Class I	Active
Strongyloides IgG ELISA Test Kit	GSD01-3012	FDA UDI	Class I	Active
ThunderBolt EIA (CLIA)	00300-CLR	FDA UDI	Class I	Active
Gold Standard Diagnostics Is-Anti-PR3 (C-ANCA) IgG ELISA Test Kit	720-440	FDA UDI	Class II	Active
GSD RPR Microtiterplate - 5 pack sleeve	GSD05-1600-W	FDA UDI	Class II	Active
Gold Standard Diagnostics Is-Anti-MPO (P-ANCA) IgG ELISA Test Kit	720-430	FDA UDI	Class II	Active
Gold Standard Diagnostics Is-anti-Sm/RNP ELISA Test Kit	720-270	FDA UDI	Class II	Active
Influenza A IgG ELISA Test Kit	GSD01-3009	FDA UDI	Class I	Active
Gold Standard Diagnostics Is-VZV IgG ELISA Test Kit	720-380	FDA UDI	Class II	Active
Gold Standard Diagnostics Is-Measles IgG ELISA Test Kit	720-520	FDA UDI	Class I	Active
Bolt (CLIA)	00500-CLR	FDA UDI	Class I	Active
Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit	GSD01-1022	FDA UDI	Class II	Active
Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit	GSD10-1022	FDA UDI	Class II	Active
Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit	GSD01-1019	FDA UDI	Class II	Unknown
IgM Reagent Pack	GSD01-1002-RP	FDA UDI	Class I	Unknown
HHV-6 IgM Sera Pack	GSD05-1701-SP	FDA UDI	Class I	Active
Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit	GSD01-1029	FDA UDI	N	Unknown
Gold Standard Diagnostics SARS-CoV-2 IgM ELISA Test Kit	GSD01-1030	FDA UDI	N	Unknown
AIX1000 Analyzer	00400	EUDAMEDFDA UDI	IVD General	Active
Gold Standard Diagnostics RPR Reagent Pack	GSD34-1600-R	EUDAMEDFDA UDI	IVD General	Active
Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit	K200025	FDA 510(k)	Class II	Active
Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System	K150358	FDA 510(k)	Class II	Active
Borrelia Burgdorferi Igm Blot Test	K113846	FDA 510(k)	Class II	Active
Helicobacter Pylori Elisa Igg Test Kit	K110745	FDA 510(k)	Class I	Active
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit	K180264	FDA 510(k)	Class II	Active
Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit	K203296	FDA 510(k)	Class II	Active
Borrelia Burgdorferi Igg Blot Test	K113847	FDA 510(k)	Class II	Active
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit	K203292	FDA 510(k)	Class II	Active
Gold Standard Diagnostics Anti-Nuclear Antibody (ana) Screen Elisa Test Kit	K131330	FDA 510(k)	Class II	Active
Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit	K203289	FDA 510(k)	Class II	Active
Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System	K250249	FDA 510(k)	Class II	Active
Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit	K203295	FDA 510(k)	Class II	Active
Herpes Simplex Virus Type 1 Igg Elisa Test	K131334	FDA 510(k)	Class II	Active
Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit	K200023	FDA 510(k)	Class II	Active
ThunderBolt EIA	00300	EUDAMEDFDA UDI	Class A	Active

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