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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: +1 530 759 8000
PRRC Contact: Tony Sanford
EUDAMED SRN: US-MF-000027142
FDA FEI Number: 3007208259
DUNS Number: —

Catalogue (107)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
Influenza B IgG ELISA Test Kit	GSD01-3010	FDA UDI	Class I	Active
RPR Non-Reactive Control	GSD05-1600-NC	FDA UDI	Class II	Active
Gold Standard Diagnostics Is-EBNA-1 IgG ELISA Test Kit	720-620	FDA UDI	Class I	Active
Gold Standard Diagnostics Is-CMV IgG ELISA Test Kit	720-320	FDA UDI	Class II	Active
Gold Standard Diagnostics Is-Anti-TPO IgG ELISA Test Kit	720-450	FDA UDI	Class II	Active
Gold Standard Diagnostics Is-ANA Screen ELISA Test Kit	720-790	FDA UDI	Class II	Active
Gold Standard Diagnostics Borrelia burgodorferi B31 IgM Line Blot Test Kit	GSD06-1019	FDA UDI	Class II	Unknown
Gold Standard Diagnostics Is-anti-SS-A ELISA Test Kit	720-250	FDA UDI	Class II	Active
Gold Standard Diagnostics H. pylori ELISA IgG Test Kit	GSD01-1000	FDA UDI	Class I	Active
Echinococcus IgG ELISA Test Kit	GSD01-3003	FDA UDI	Class I	Active
Gold Standard Diagnostics Is-Mumps IgG ELISA Test Kit	720-540	FDA UDI	Class I	Active
Gold Standard Diagnostics SARS-CoV-2 IgG ELISA Test Kit	GSD01-1028	FDA UDI	N	Unknown
Gold Standard Diagnostics Is-EBNA-1 IgM ELISA Test Kit	720-630	FDA UDI	Class I	Active
GSD Brucella IgG ELISA	GSD01-3007	FDA UDI	Class II	Active
GSD Toxocara canis IgG ELISA	GSD01-3000	FDA UDI	Class I	Unknown
Trichinella spiralis IgG ELISA Test Kit	GSD01-3002	FDA UDI	Class I	Active
H. pylori Component Pack	GSD01-1002-HCP	FDA UDI	Class I	Unknown
Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit	GSD10-1023	FDA UDI	Class II	Active
Microtiterplates (5)	GSD05-1600-MW	FDA UDI	Class II	Active
Gold Standard Diagnostics Is-anti-dsDNA ELISA Test Kit	720-700	FDA UDI	Class II	Active
Gold Standard Diagnostics H. pylori ELISA IgA Test Kit	GSD01-1001	FDA UDI	Class I	Unknown
IgG Component Pack - Bulk	GSD05-1700-CP	FDA UDI	Class I	Active
Gold Standard Diagnostics Anti-nuclear Antibody (ANA) Screening Test Kit	GSD01-1300	FDA UDI	Class II	Unknown
Gold Standard Diagnostics Is-anti-Sm ELISA Test Kit	720-240	FDA UDI	Class II	Active
Leishmania infantum IgG Level 3 Serum	GSD01-3006-L3	FDA UDI	Class I	Active
AIX1000 Analyzer	00400R	FDA UDI	Class II	Active
Gold Standard Diagnostics Is-HSV 1&2 IgM ELISA Test Kit	720-350	FDA UDI	Class II	Active
Gold Standard Diagnostics Is-EBV-EA-D IgG Test Kit	720-640	FDA UDI	Class I	Active
IgM Component Pack - Bulk	GSD05-1701-CP	FDA UDI	Class I	Active
Leishmania infantum Antigen Wells	GSD01-3006-AW	FDA UDI	Class I	Active
Gold Standard Diagnostics Borrelia burgodorferi IgG/IgM ELISA Test Kit	GSD10-1024	FDA UDI	Class II	Unknown
Gold Standard Diagnostics Is-EBV-EA-D IgM Test Kit	720-650	FDA UDI	Class I	Active
Bolt	00500R	FDA UDI	Class I	Active
Leishmania infantum IgG Level 1 Serum	GSD01-3006-L1	FDA UDI	Class I	Active
ThunderBolt EIA	00300R	FDA UDI	Class I	Active
SARS-CoV-2 IgA Sera Pack	GSD01-1029-SP	FDA UDI	Class I	Unknown
Gold Standard Diagnostics Is-Anti-TG IgG ELISA Test Kit	720-460	FDA UDI	Class II	Active
HHV-6 IgG Sera Pack	GSD05-1700-SP	FDA UDI	Class I	Active
Gold Standard Diagnostics Is-HSV 1&2 IgG ELISA Test Kit	720-340	FDA UDI	Class II	Active
Gold Standard Diagnostics Is-Rubella IgG ELISA Test Kit	720-360	FDA UDI	Class II	Active
Gold Standard Diagnostics Is-anti-SS-B ELISA Test Kit	720-260	FDA UDI	Class II	Active
Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit - Bulk	GSD04-1022	FDA UDI	Class II	Unknown
Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit	GSD01-1018	FDA UDI	Class II	Unknown
Gold Standard Diagnostics Is-Toxoplasma IgG ELISA Test Kit	720-300	FDA UDI	Class II	Active
Performance Check Dye Kit	GSD01-2450	FDA UDI	Class I	Active
Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit	GSD01-1025	FDA UDI	Class II	Active
Toxocara canis IgG ELISA Test Kit	GSD01-3001	FDA UDI	Class I	Active
Gold Standard Diagnostics Is-EBV-VCA IgM Test Kit	720-610	FDA UDI	Class I	Active
Gold Standard Diagnostics Is-EBV-VCA IgG Test Kit	720-600	FDA UDI	Class I	Active
AIX1000 Performance Check Dye Kit	GSD01-1600-DYE	FDA UDI	Class II	Active

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