This page includes the latest FDA filings for Gold Standard Diagnostics Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3007208259 |
| FEI Number | 3007208259 |
| Name | GOLD STANDARD DIAGNOSTICS CORP. |
| Owner & Operator | Gold Standard Diagnostics |
| Contact Address | 2851 spafford street Davis CA 95618 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 2851 spafford street Davis, CA 95618 US |
| Establishment Type |
|
Device Company | Device | Date |
|---|---|---|
| Gold Standard Diagnostics Corporation | Bolt 00500R | 2023-11-08 |
| Gold Standard Diagnostics Corporation | Bolt (CLIA) 00500-CLR | 2023-11-08 |
| Gold Standard Diagnostics Corporation | AIX1000 Analyzer 00400R | 2023-11-08 |
| Gold Standard Diagnostics Corporation | ThunderBolt EIA 00300R | 2023-11-08 |
| Gold Standard Diagnostics Corporation | ThunderBolt EIA (CLIA) 00300-CLR | 2023-11-08 |
| Gold Standard Diagnostics Corporation | RPR Reactive Control GSD05-1600-PC | 2023-09-21 |
| Gold Standard Diagnostics Corporation | RPR Non-Reactive Control GSD05-1600-NC | 2023-09-21 |
| Gold Standard Diagnostics Corporation | Performance Check Dye Kit GSD01-2450 | 2023-09-21 |
| Gold Standard Diagnostics Corporation | AIX1000 Performance Check Dye Kit GSD01-1600-DYE | 2023-09-21 |
| Gold Standard Diagnostics Corporation | Leishmania infantum IgG Level 3 Serum GSD01-3006-L3 | 2023-03-23 |
| Gold Standard Diagnostics Corporation | Leishmania infantum IgG Level 2 Serum GSD01-3006-L2 | 2023-03-23 |
| Gold Standard Diagnostics Corporation | Leishmania infantum IgG Level 1 Serum GSD01-3006-L1 | 2023-03-23 |
| Gold Standard Diagnostics Corporation | Leishmania infantum Antigen Wells GSD01-3006-AW | 2023-03-23 |
| Gold Standard Diagnostics Corporation | HHV-6 IgM Sera Pack GSD05-1701-SP | 2022-12-15 |
| Gold Standard Diagnostics Corporation | IgM Component Pack - Bulk GSD05-1701-CP | 2022-12-15 |
| Gold Standard Diagnostics Corporation | HHV-6 IgM Plates - Bulk GSD05-1701-AW | 2022-12-15 |
| Gold Standard Diagnostics Corporation | HHV-6 IgG Sera Pack GSD05-1700-SP | 2022-12-15 |
| Gold Standard Diagnostics Corporation | Influenza A IgG ELISA Test Kit GSD01-3009 | 2022-12-15 |
| Gold Standard Diagnostics Corporation | Echinococcus IgG ELISA Test Kit GSD01-3003 | 2022-12-15 |
| Gold Standard Diagnostics Corporation | Gold Standard Diagnostics Is-EBV-EA-D IgM Test Kit 720-650 | 2022-12-15 |
| Gold Standard Diagnostics Corporation | Gold Standard Diagnostics Is-EBV-EA-D IgG Test Kit 720-640 | 2022-12-15 |
| Gold Standard Diagnostics Corporation | Gold Standard Diagnostics Is-EBNA-1 IgG ELISA Test Kit 720-620 | 2022-12-15 |
| Gold Standard Diagnostics Corporation | Gold Standard Diagnostics Is-EBV-VCA IgM Test Kit 720-610 | 2022-12-15 |
| Gold Standard Diagnostics Corporation | Gold Standard Diagnostics Is-EBV-VCA IgG Test Kit 720-600 | 2022-12-15 |
| Gold Standard Diagnostics Corporation | Gold Standard Diagnostics Is-Toxoplasma IgG ELISA Test Kit 720-300 | 2022-12-13 |
| Gold Standard Diagnostics Corporation | Gold Standard Diagnostics Is-anti-Jo-1 ELISA Test Kit 720-290 | 2022-12-13 |
| Gold Standard Diagnostics Corporation | Gold Standard Diagnostics Is-anti-Sm/RNP ELISA Test Kit 720-270 | 2022-12-13 |
| Gold Standard Diagnostics Corporation | Gold Standard Diagnostics Is-anti-SS-B ELISA Test Kit 720-260 | 2022-12-13 |
| Gold Standard Diagnostics Corporation | Gold Standard Diagnostics Is-anti-SS-A ELISA Test Kit 720-250 | 2022-12-13 |
| Gold Standard Diagnostics Corporation | Gold Standard Diagnostics Is-Rheumatoid Factor ELISA Test Kit 720-710 | 2022-12-12 |
| Gold Standard Diagnostics Corporation | Gold Standard Diagnostics Is-anti-dsDNA ELISA Test Kit 720-700 | 2022-12-12 |
| Gold Standard Diagnostics Corporation | Gold Standard Diagnostics Is-Anti-TG IgG ELISA Test Kit 720-460 | 2022-12-12 |
| Gold Standard Diagnostics Corporation | Gold Standard Diagnostics Is-Anti-TPO IgG ELISA Test Kit 720-450 | 2022-12-12 |
| Gold Standard Diagnostics Corporation | Gold Standard Diagnostics Is-Anti-PR3 (C-ANCA) IgG ELISA Test Kit 720-440 | 2022-12-12 |
| Gold Standard Diagnostics Corporation | Gold Standard Diagnostics Is-Anti-MPO (P-ANCA) IgG ELISA Test Kit 720-430 | 2022-12-12 |
| Gold Standard Diagnostics Corporation | Gold Standard Diagnostics Is-anti-Sm ELISA Test Kit 720-240 | 2022-12-12 |
| Gold Standard Diagnostics Corporation | GSD RPR Microtiterplate - 5 pack sleeve GSD05-1600-W | 2022-12-05 |
| Gold Standard Diagnostics Corporation | Strongyloides IgG ELISA Test Kit GSD01-3012 | 2022-12-05 |
| Gold Standard Diagnostics Corporation | Entamoeba histolytica IgG ELISA Test Kit GSD01-3013 | 2022-11-28 |
| Gold Standard Diagnostics Corporation | Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit GSD01-1031 | 2022-11-07 |
| Gold Standard Diagnostics Corporation | IgM Reagent Pack GSD01-1002-RP | 2022-11-07 |
| Gold Standard Diagnostics Corporation | Microtiterplates GSD-1600-W-CASE | 2022-10-24 |
| Gold Standard Diagnostics Corporation | IgG Component Pack - Bulk GSD05-1700-CP | 2022-10-24 |
| Gold Standard Diagnostics Corporation | Trichinella spiralis IgG ELISA Test Kit GSD01-3002 | 2022-10-24 |
| Gold Standard Diagnostics Corporation | Toxocara canis IgG ELISA Test Kit GSD01-3001 | 2022-10-24 |
| Gold Standard Diagnostics Corporation | HHV-6 IgG Plates - Bulk GSD05-1700-AW | 2022-10-17 |
| Gold Standard Diagnostics Corporation | Influenza B IgG ELISA Test Kit GSD01-3010 | 2022-10-17 |
| Gold Standard Diagnostics Corporation | SARS-CoV-2 IgA Sera Pack GSD01-1029-SP | 2022-10-17 |
| Gold Standard Diagnostics Corporation | SARS-CoV-2 Component Pack GSD01-1029-CP | 2022-10-17 |
| Gold Standard Diagnostics Corporation | H. pylori Component Pack GSD01-1002-HCP | 2022-10-17 |
| Gold Standard Diagnostics Corporation | H. pylori IgM Sera Pack GSD01-1002-CP | 2022-10-17 |
| Gold Standard Diagnostics Corporation | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit GSD01-1026 | 2022-10-03 |
| Gold Standard Diagnostics Corporation | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit GSD01-1025 | 2022-10-03 |
| Gold Standard Diagnostics Corporation | Bolt (CLIA) 00500CL | 2022-10-03 |
| Gold Standard Diagnostics Corporation | Bolt 00500 | 2022-10-03 |
| Gold Standard Diagnostics Corporation | ThunderBolt EIA (CLIA) 00300CL | 2022-10-03 |
| Gold Standard Diagnostics Corporation | ThunderBolt EIA 00300 | 2022-10-03 |
| Gold Standard Diagnostics Corporation | Gold Standard Diagnostics Borrelia burgdorferi VIsE-OspC ELISA IgG/ IgM Test Kit GSD01-1027 | 2021-07-28 |
| Gold Standard Diagnostics Corporation | Gold Standard Diagnostics SARS-CoV-2 IgG ELISA Test Kit GSD01-1028 | 2021-06-04 |
| Gold Standard Diagnostics Corporation | Gold Standard Diagnostics Is-Measles IgG ELISA Test Kit 720-520 | 2021-06-04 |
| Gold Standard Diagnostics Corporation | Gold Standard Diagnostics Is-VZV IgG ELISA Test Kit 720-380 | 2021-06-04 |
| GOLD STANDARD DIAGNOSTICS CORP. | Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit GSD01-1029 | 2021-01-12 |
| GOLD STANDARD DIAGNOSTICS CORP. | Gold Standard Diagnostics Is-HSV 1&2 IgG ELISA Test Kit 720-340 | 2020-09-07 |
| GOLD STANDARD DIAGNOSTICS CORP. | Gold Standard Diagnostics Is-EBNA-1 IgM ELISA Test Kit 720-630 | 2020-08-04 |
| GOLD STANDARD DIAGNOSTICS CORP. | Gold Standard Diagnostics Is-Mumps IgG ELISA Test Kit 720-540 | 2020-08-04 |
| GOLD STANDARD DIAGNOSTICS CORP. | Gold Standard Diagnostics Is-Rubella IgG ELISA Test Kit 720-360 | 2020-08-04 |
| GOLD STANDARD DIAGNOSTICS CORP. | Gold Standard Diagnostics Is-anti-Scl-70 ELISA Test Kit 720-280 | 2020-08-04 |
| GOLD STANDARD DIAGNOSTICS CORP. | Gold Standard Diagnostics SARS-CoV-2 IgM ELISA Test Kit GSD01-1030 | 2020-07-28 |
| GOLD STANDARD DIAGNOSTICS CORP. | Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit GSD01-1023 | 2020-07-09 |
| GOLD STANDARD DIAGNOSTICS CORP. | Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit GSD01-1022 | 2020-07-09 |
| GOLD STANDARD DIAGNOSTICS CORP. | Gold Standard Diagnostics Is-HSV 1&2 IgM ELISA Test Kit 720-320 | 2020-06-11 |
| GOLD STANDARD DIAGNOSTICS CORP. | Gold Standard Diagnostics Is-CMV IgG ELISA Test Kit 720-320 | 2020-06-11 |
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics] | GSD SARS-CoV-2 IgG ELISA Test Kit; GSD SARS-CoV-2 IgM ELISA Test Kit; GSD SARS-CoV-2 IgA ELISA Test Kit | 2020-04-15 |
| GOLD STANDARD DIAGNOSTICS CORP. | Gold Standard Diagnostics Borrelia burgdorferi B31 GSD10-1023 | 2018-07-06 |
| GOLD STANDARD DIAGNOSTICS CORP. | Gold Standard Diagnostics Borrelia burgodorferi B3 GSD10-1022 | 2018-07-06 |
| GOLD STANDARD DIAGNOSTICS CORP. | Gold Standard Diagnostics Borrelia burgdorferi B31 GSD04-1023 | 2018-07-06 |
| GOLD STANDARD DIAGNOSTICS CORP. | Gold Standard Diagnostics Borrelia burgdorferi B31 GSD04-1022 | 2018-07-06 |
| GOLD STANDARD DIAGNOSTICS CORP. | Gold Standard Diagnostics Borrelia burgodorferi Ig GSD10-1024 | 2018-07-06 |
| GOLD STANDARD DIAGNOSTICS CORP. | Gold Standard Diagnostics Borrelia burgdorferi B31 GSD01-1019 | 2018-07-06 |
| GOLD STANDARD DIAGNOSTICS CORP. | Gold Standard Diagnostics Borrelia burgodorferi B3 GSD01-1018 | 2018-07-06 |
| GOLD STANDARD DIAGNOSTICS CORP. | AIX1000 Analyzer | 2018-07-06 |
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics] | Gold Standard Diagnostics Borrelia borgdorferi IgG/IgM ELISA Test Kit | 2018-05-15 |
| GOLD STANDARD DIAGNOSTICS CORP. | Gold Standard Diagnostics RPR Reagent Pack GSD34-1600-R | 2018-03-29 |
| GOLD STANDARD DIAGNOSTICS CORP. | Gold Standard Diagnostics Borrelia burgodorferi B3 | 2018-03-29 |
| GOLD STANDARD DIAGNOSTICS CORP. | Gold Standard Diagnostics Borrelia burgodorferi B3 | 2018-03-29 |
| GOLD STANDARD DIAGNOSTICS CORP. | GSD Brucella IgG ELISA GSD01-3007 | 2018-03-29 |
| GOLD STANDARD DIAGNOSTICS CORP. | GSD Toxocara canis IgG ELISA GSD01-3000 | 2018-03-29 |
| GOLD STANDARD DIAGNOSTICS CORP. | Gold Standard Diagnostics Rapid Plasma Reagin (RPR | 2018-03-29 |
| GOLD STANDARD DIAGNOSTICS CORP. | Gold Standard Diagnostics Anti-nuclear Antibody (A | 2018-03-29 |
| GOLD STANDARD DIAGNOSTICS CORP. | Gold Standard Diagnostics H. pylori ELISA IgA Test | 2018-03-29 |
| GOLD STANDARD DIAGNOSTICS CORP. | Gold Standard Diagnostics H. pylori ELISA IgG Test | 2018-03-29 |
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics] | Toxocara Canis IgG | 2017-06-13 |
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics] | Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System | 2015-12-14 |
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics] | HHV-6 Serum Level 1, 2, 3 | 2014-12-02 |
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics] | HHV-6 Antigen Wells | 2014-12-02 |
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics] | H.pylori Serum Level 1, 2, 3 | 2014-12-02 |
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics] | Gold Standard Diagnostics Antinuclear Antibody (ANA) Screen ELISA Test Kit | 2014-02-03 |
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics] | Mumps IgG ELISA Kit | 2013-01-25 |
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics] | GSD Trichinella Spiralis IgG ELISA Test Kit | 2012-12-12 |
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics] | GSD Strongyloidies IgG ELISA Test | 2012-12-12 |
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics] | GSD Entamoeba Histolytica ELISA Test Kit | 2012-12-12 |
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics] | Brucella IgG ELISA | 2012-12-12 |
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics] | GSD Echinococcus ELISA Test Kit | 2012-12-12 |
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics] | Gold Standard Diagnostics Influenza B IgG ELISA Test | 2012-12-12 |
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics] | Gold Standard Diagnostics Influenza A IgG ELISA Test | 2012-12-12 |
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics] | Gold Standard Diagnostics Borrelia Burgdorferi B31 IgM Line | 2012-08-03 |
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics] | Gold Standard Diagnostics Borrelia Burgdorferi B31 IgG Line Blot Test | 2012-05-18 |
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics] | Gold Standard Diagnostics H. Pylori IgG ELISA Test Kit | 2012-05-18 |
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics] | Thunderbolt EIA | 2012-05-18 |
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics] | Thunderbolt EIA-CL | 2012-05-18 |
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics] | Bolt EIA / EIA-CL | 2012-05-18 |
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics] | Gold Standard Diagnostics H. pylori IgA ELISA Test Kit | 2012-02-27 |
| NCAGE Code | 5BXW0 | GOLD STANDARD DIAGNOSTICS CORP. |
| CAGE Code | 5BXW0 | GOLD STANDARD DIAGNOSTICS CORP. |
| S.A.M. Registration | 5BXW0 [790524891] | GOLD STANDARD DIAGNOSTICS CORP. |
| SEC | 0001491777 | Gold Standard Diagnostics Corp. of DELAWARE |