Data / Medical devices / United States / Gold Standard Diagnostics, LLC
Gold Standard Diagnostics, LLC: FDA-registered device maker in Davis, CA, United States, 37 510(k) clearances
Gold Standard Diagnostics, LLC is registered with the FDA (registration 3007208259) in Davis, CA, United States. It lists 26 device types. The FDA files 37 510(k) clearances under its listings, the newest dated October 10, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007208259
- Address
- 2795 2nd St Ste 300, Davis, CA, United States, 95618
- Owner or operator
- Gold Standard Diagnostics (10025460)
- Roles
- Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- May 18, 2012
- Registered through
- 2026
- Brand names listed
- Bolt, Bolt (CLIA), Echinococcus IgG ELISA Test Kit, Entamoeba histolytica IgG ELISA Test Kit, GSD Brucella IgG ELISA, Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System, Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System, Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 10, 2025 | K250249 | Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System | GMQ | Substantially Equivalent | Gold Standard Diagnostics, LLC | accessdata.fda.gov |
| March 22, 2021 | K203296 | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit | LSR | Substantially Equivalent | Gold Standard Diagnostics | accessdata.fda.gov |
| March 22, 2021 | K203295 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit | LSR | Substantially Equivalent | Gold Standard Diagnostics | accessdata.fda.gov |
| March 22, 2021 | K203292 | Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit | LSR | Substantially Equivalent | Gold Standard Diagnostics | accessdata.fda.gov |
| March 22, 2021 | K203289 | Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit | LSR | Substantially Equivalent | Gold Standard Diagnostics | accessdata.fda.gov |
| April 6, 2020 | K200025 | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit | LSR | Substantially Equivalent | Gold Standard Diagnostics | accessdata.fda.gov |
| April 6, 2020 | K200023 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit | LSR | Substantially Equivalent | Gold Standard Diagnostics | accessdata.fda.gov |
| November 12, 2015 | K150358 | Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System | GMQ | Substantially Equivalent | Gold Standard Diagnostics | accessdata.fda.gov |
| June 1, 2012 | K113846 | BORRELIA BURGDORFERI IGM BLOT TEST | LSR | Substantially Equivalent | Gold Standard Diagnostics | accessdata.fda.gov |
| April 11, 2012 | K113847 | BORRELIA BURGDORFERI IGG BLOT TEST | LSR | Substantially Equivalent | Gold Standard Diagnostics | accessdata.fda.gov |
| July 9, 2002 | K021394 | DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM | DHR | Substantially Equivalent | Diamedix Corp. | accessdata.fda.gov |
| November 28, 2000 | K002262 | DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM | LGC | Substantially Equivalent | Diamedix Corp. | accessdata.fda.gov |
| February 18, 2000 | K994424 | DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM | LRM | Substantially Equivalent | Diamedix Corp. | accessdata.fda.gov |
| October 25, 1999 | K993294 | DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM | LKJ | Substantially Equivalent | Diamedix Corp. | accessdata.fda.gov |
| September 3, 1999 | K991274 | MUMPS IGG ELISA TEST SYSTEM | LJY | Substantially Equivalent | Columbia Bioscience, Inc. | accessdata.fda.gov |
| March 4, 1999 | K981812 | EBV-VCA IGG ELISA TEST SYSTEM | LSE | Substantially Equivalent | Diamedix Corp. | accessdata.fda.gov |
| February 16, 1999 | K981831 | IS EBV-EA-D IGG ELISA TEST SYSTEM | GNP | Substantially Equivalent | Diamedix Corp. | accessdata.fda.gov |
| February 16, 1999 | K981829 | IS EBV-EBNA-1 IGG ELISA TEST SYSTEM | GNP | Substantially Equivalent | Diamedix Corp. | accessdata.fda.gov |
| February 2, 1999 | K984228 | IS ANTI-TPO IGG ELISA TEST SYSTEM | JZO | Substantially Equivalent | Columbia Bioscience, Inc. | accessdata.fda.gov |
| January 28, 1999 | K981729 | IS-RUBELLA IGG TEST SYSTEM | LFX | Substantially Equivalent | Diamedix Corp. | accessdata.fda.gov |
| December 7, 1998 | K983553 | ANTI-TG IGG ELISA TEST SYSTEM | JZO | Substantially Equivalent | Columbia Bioscience, Inc. | accessdata.fda.gov |
| November 25, 1998 | K982352 | VCA IGM ELISA TEST SYSTEM | LSE | Substantially Equivalent | Columbia Bioscience, Inc. | accessdata.fda.gov |
| November 25, 1998 | K982350 | EA-D IGM ELISA TEST SYSTEM | LSE | Substantially Equivalent | Columbia Bioscience, Inc. | accessdata.fda.gov |
| November 25, 1998 | K982348 | EBNA-1 IGM ELISA TEST SYSTEM | LSE | Substantially Equivalent | Columbia Bioscience, Inc. | accessdata.fda.gov |
| November 18, 1998 | K983740 | IS-ANTI-PR3 IGG ELISA TEST SYSTEM | MOB | Substantially Equivalent | Columbia Bioscience, Inc. | accessdata.fda.gov |
| November 18, 1998 | K983390 | IS-ANTI-MPO IGG ELISA TEST SYSTEM | MOB | Substantially Equivalent | Columbia Bioscience, Inc. | accessdata.fda.gov |
| September 29, 1998 | K981306 | DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM | LGC | Substantially Equivalent | Diamedix Corp. | accessdata.fda.gov |
| September 28, 1998 | K981867 | IS-VZU IGG TEST SYSTEM | LFY | Substantially Equivalent | Diamedix Corp. | accessdata.fda.gov |
| September 21, 1998 | K981163 | DIAMEDIX IS-CMV IGG TEST SYSTEM | LFZ | Substantially Equivalent | Diamedix Corp. | accessdata.fda.gov |
| August 21, 1998 | K981498 | IS-TOXOPLASMA IGG TEST SYSTEM | LGD | Substantially Equivalent | Diamedix Corp. | accessdata.fda.gov |
| January 28, 1998 | K974552 | DIAMEDIX IS-MEASLES IGG TEST SYSTEM | LJB | Substantially Equivalent | Diamedix Corp. | accessdata.fda.gov |
| April 8, 1997 | K970239 | IS-ANTI-SCL-70 TEST SYSTEM (720-280) | LLL | Substantially Equivalent | Diamedix Corp. | accessdata.fda.gov |
| April 8, 1997 | K970238 | IS-ANTI-SM/RNP (720-270) | LLL | Substantially Equivalent | Diamedix Corp. | accessdata.fda.gov |
| April 8, 1997 | K970237 | IS-ANTI-SSB TEST SYSTEM (720-260) | LLL | Substantially Equivalent | Diamedix Corp. | accessdata.fda.gov |
| April 8, 1997 | K970228 | IS-ANTI-JO-1 TEST SYSTEM | LLL | Substantially Equivalent | Diamedix Corp. | accessdata.fda.gov |
| April 8, 1997 | K970220 | IS-ANTI-SM TEST SYSTEM | LLL | Substantially Equivalent | Diamedix Corp. | accessdata.fda.gov |
| April 8, 1997 | K970218 | IS-ANTI-SSA TEST SYSTEM | LLL | Substantially Equivalent | Diamedix Corp. | accessdata.fda.gov |
Compare with other makers
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Updated October 10, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.