GOLD STANDARD DIAGNOSTICS, LLC

Registration Details

Registration Name: GOLD STANDARD DIAGNOSTICS, LLC
Registration Number: 3007208259
FEI Number: 3007208259
Status: Active
Expiry Year: 2026
Initial Importer: Yes
Address: 2795 2nd St Ste 300
City: Davis
State: CA
ZIP: 95618
Country: US

Regulatory Submissions

510(k) Number: K150358

Owner / Operator

Firm Name: Gold Standard Diagnostics
Operator Number: 10025460
Address: 2795 2nd Street, Suite 300
City: Davis
State: CA
Postal Code: 95618
Country: US

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Antigens, Nontreponemal, All	GMQ	Class 2	Microbiology	No	2015-12-14
Enzyme Linked Immunoabsorbent Assay, Mumps Virus	LJY	Class 1	Microbiology	No	2020-07-20
Reagent, Borrelia Serological Reagent	LSR	Class 2	Microbiology	No	2012-05-18
Epstein-Barr Virus, Other	LSE	Class 1	Microbiology	No	2021-08-03
Enzyme Linked Immunoabsorbent Assay, Rubella	LFX	Class 2	Microbiology	No	2020-07-13
Antisera, Cf, Influenza Virus A, B, C	GNW	Class 1	Microbiology	No	2012-12-12
System, Test, Rheumatoid Factor	DHR	Class 2	Immunology	No	2020-11-02
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus	LFZ	Class 2	Microbiology	No	2020-05-18
Reagents, Specific, Analyte	MVU	Class 1	Pathology	No	2014-12-02
Extractable Antinuclear Antibody, Antigen And Control	LLL	Class 2	Immunology	No	2020-10-09
System, Test, Thyroid Autoantibody	JZO	Class 2	Immunology	No	2020-09-04
Antinuclear Antibody, Antigen, Control	LKJ	Class 2	Immunology	No	2025-02-24
Elisa, Trichinella Spiralis	MDT	Class 1	Microbiology	No	2012-12-12
Instrumentation For Clinical Multiplex Test Systems	NSU	Class 2	Clinical Chemistry	No	2025-06-23
Antisera, Fluorescent, Brucella Spp.	GSM	Class 2	Microbiology	No	2012-12-12
General Purpose Reagent	PPM	Class 1	Pathology	No	2022-09-28
Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	MOB	Class 2	Immunology	No	2021-01-15
Antiserum, Cf, Epstein-Barr Virus	GNP	Class 1	Microbiology	No	2021-04-23
Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster	LFY	Class 2	Microbiology	No	2020-05-18
Antigen, Agglutinating, Echinococcus Spp.	GPF	Class 1	Microbiology	No	2012-12-12
Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.	KHW	Class 2	Microbiology	No	2012-12-12
Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control	LRM	Class 2	Immunology	No	2020-12-15
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	Class 1	Clinical Chemistry	No	2012-05-18
Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific	LGC	Class 2	Microbiology	No	2020-08-28
Enzyme Linked Immunoabsorbent Assay, Rubeola Igg	LJB	Class 1	Microbiology	No	2020-05-18
Helicobacter Pylori	LYR	Class 1	Microbiology	No	2012-05-18
Reagents, Cysticercosis	MDJ	Class 1	Microbiology	No	2017-06-13
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	LGD	Class 2	Microbiology	No	2020-12-15

Proprietary Names

Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System Gold Standard Diagnostics Is-Mumps IgG ELISA Test Kit Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit Gold Standard Diagnostics Is-EBV-EA-D IgM Test Kit Gold Standard Diagnostics Is-Rubella IgG ELISA Test Kit Influenza B IgG ELISA Test Kit Influenza A IgG ELISA Test Kit Gold Standard Diagnostics Is-Rheumatoid Factor ELISA Test Kit Gold Standard Diagnostics Is-CMV IgG ELISA Test Kit HHV-6 IgG Sera Pack HHV-6 IgM Plates - Bulk HHV-6 IgM Sera Pack HHV-6 IgG Plates - Bulk Leishmania infantum Antigen Wells Leishmania infantum IgG Level 2 Serum Leishmania infantum IgG Level 1 Serum Leishmania infantum IgG Level 3 Serum Gold Standard Diagnostics Is-anti-Jo-1 ELISA Test Kit Gold Standard Diagnostics Is-anti-SS-A ELISA Test Kit Gold Standard Diagnostics Is-Anti-TG IgG ELISA Test Kit Gold Standard Diagnostics Is-ANA Screen ELISA Test Kit Strongyloides IgG ELISA Test Kit Trichinella spiralis IgG ELISA Test Kit HAILSTORM GSD Brucella IgG ELISA IgG Component Pack - Bulk IgM Component Pack - Bulk Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit Gold Standard Diagnostics Is-Anti-PR3 (C-ANCA) IgG ELISA Test Kit Gold Standard Diagnostics Is-EBNA-1 IgG ELISA Test Kit Gold Standard Diagnostics Is-anti-Scl-70 ELISA Test Kit Gold Standard Diagnostics Is-EBV-EA-D IgG Test Kit Gold Standard Diagnostics Is-EBV-VCA IgM Test Kit Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit Gold Standard Diagnostics Is-VZV IgG ELISA Test Kit Echinococcus IgG ELISA Test Kit Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC ELISA IgG/ IgM Test Kit Entamoeba histolytica IgG ELISA Test Kit Gold Standard Diagnostics Is-anti-dsDNA ELISA Test Kit Gold Standard Diagnostics Is-anti-SS-B ELISA Test Kit Gold Standard Diagnostics Is-EBV-VCA IgG Test Kit Gold Standard Diagnostics Is-anti-Sm ELISA Test Kit Gold Standard Diagnostics Is-anti-Sm/RNP ELISA Test Kit Gold Standard Diagnostics Is-Anti-TPO IgG ELISA Test Kit Performance Check Dye Kit Bolt Thunderbolt EIA (CLIA) Thunderbolt EIA Bolt (CLIA) Gold Standard Diagnostics Is-HSV 1&2 IgG ELISA Test Kit Gold Standard Diagnostics Is-Measles IgG ELISA Test Kit Gold Standard Diagnostics Is-Anti-MPO (P-ANCA) IgG ELISA Test Kit Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System Gold Standard Diagnostics Is-EBNA-1 IgM ELISA Test Kit Gold Standard Diagnostics Is-HSV 1&2 IgM ELISA Test Kit Gold Standard Diagnostics H. pylori ELISA IgG Test Kit Toxocara canis IgG ELISA Test Kit Gold Standard Diagnostics Is-Toxoplasma IgG ELISA Test Kit

Establishment Types

Repack or Relabel Medical Device Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Device in the United States for Export Only