Gold Standard Diagnostics, LLC
Davis, CA, US
GOLD STANDARD DIAGNOSTICS, LLC appears in FDA device records in Davis, CA. FDA records list 15 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 15 510(k) clearances for Gold Standard Diagnostics, LLC between 2012 and 2025. The busiest year on record is 2012, with 4. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 4 |
| 2014 | 2 |
| 2015 | 1 |
| 2018 | 1 |
| 2020 | 2 |
| 2021 | 4 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250249 | Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System | GMQ | Substantially Equivalent | |
| K203296 | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit | LSR | Substantially Equivalent | |
| K203295 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit | LSR | Substantially Equivalent | |
| K203292 | Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit | LSR | Substantially Equivalent | |
| K203289 | Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit | LSR | Substantially Equivalent | |
| K200025 | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit | LSR | Substantially Equivalent | |
| K200023 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit | LSR | Substantially Equivalent | |
| K180264 | Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit | LSR | Substantially Equivalent | |
| K150358 | Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System | GMQ | Substantially Equivalent | |
| K131334 | HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST | MXJ | Substantially Equivalent | |
| K131330 | GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT | LJM | Substantially Equivalent | |
| K113846 | BORRELIA BURGDORFERI IGM BLOT TEST | LSR | Substantially Equivalent | |
| K113847 | BORRELIA BURGDORFERI IGG BLOT TEST | LSR | Substantially Equivalent | |
| K110745 | HELICOBACTER PYLORI ELISA IGG TEST KIT | LYR | Substantially Equivalent | |
| K110899 | GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT | LYR | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007208259 | 3007208259 | GOLD STANDARD DIAGNOSTICS, LLC | 2795 2nd St Ste 300, Davis, CA 95618 US | 2026 | and 16 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, Control
- GPFAntigen, Agglutinating, Echinococcus Spp.
- KHWAntigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
- GMQAntigens, Nontreponemal, All
- LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- LKJAntinuclear Antibody, Antigen, Control
- GSMAntisera, Fluorescent, Brucella Spp.
- GNPAntiserum, Cf, Epstein-Barr Virus
- MDTElisa, Trichinella Spiralis
- LFZEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus
- LGCEnzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
- LJYEnzyme Linked Immunoabsorbent Assay, Mumps Virus
- LFXEnzyme Linked Immunoabsorbent Assay, Rubella
- LJBEnzyme Linked Immunoabsorbent Assay, Rubeola Igg
- LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
- LFYEnzyme Linked Immunoabsorbent Assay, Varicella-Zoster
- MXJEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
- LSEEpstein-Barr Virus, Other
- LLLExtractable Antinuclear Antibody, Antigen And Control
- PPMGeneral Purpose Reagent
- LYRHelicobacter Pylori
- NSUInstrumentation For Clinical Multiplex Test Systems
- LSRReagent, Borrelia Serological Reagent
- MDJReagents, Cysticercosis
- MVUReagents, Specific, Analyte
- DHRSystem, Test, Rheumatoid Factor
- JZOSystem, Test, Thyroid Autoantibody
- MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain