This page includes the latest FDA filings for Gold Standard Diagnostics. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Gold Standard Diagnostics holds import registrations or U.S. agent authorizations in conjunction with the following organizations:
| 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 |
|
| Registration Number | 3013944136 |
| FEI Number | 3013944136 |
| Name | GOLD STANDARD DIAGNOSTICS |
| Owner & Operator | Gold Standard Diagnostics |
| Contact Address | 2851 spafford street Davis CA 95618 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 628 Cantrill Drive Davis, CA 95618 US |
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
Gold Standard Diagnostics | Gold Standard Diagnostics Borrelia Burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit | 2021-03-22 |
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 | Gold Standard Diagnostics Borrelia Burgdorferi IgG ELISA Test Kit | 2020-04-06 |
Gold Standard Diagnostics | Gold Standard Diagnostics Borrelia Burgdorferi IgM ELISA Test Kit | 2020-04-06 |
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics] | Gold Standard Diagnostics Borrelia borgdorferi IgG/IgM ELISA Test Kit | 2018-05-15 |
Gold Standard Diagnostics | Gold Standard Diagnostics Borrelia Burgdorferi IgG/IgM ELISA Test Kit | 2018-05-02 |
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 | Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System | 2015-11-12 |
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 | HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST | 2014-02-28 |
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics] | Gold Standard Diagnostics Antinuclear Antibody (ANA) Screen ELISA Test Kit | 2014-02-03 |
GOLD STANDARD DIAGNOSTICS | GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT | 2014-01-28 |
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 | BORRELIA BURGDORFERI IGM BLOT TEST | 2012-06-01 |
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 | Thunderbolt EIA | 2012-05-18 |
GOLD STANDARD DIAGNOSTICS | Thunderbolt EIA-CL | 2012-05-18 |
GOLD STANDARD DIAGNOSTICS | Bolt EIA / EIA-CL | 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 | BORRELIA BURGDORFERI IGG BLOT TEST | 2012-04-11 |
GOLD STANDARD DIAGNOSTICS | HELICOBACTER PYLORI ELISA IGG TEST KIT | 2012-03-02 |
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics] | Gold Standard Diagnostics H. pylori IgA ELISA Test Kit | 2012-02-27 |
GOLD STANDARD DIAGNOSTICS | GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT | 2012-02-01 |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 202007247991 | Stadersand,Federal Republic of Germany -> Oakland, California | ON 10 PALLETS GSD-BD-50 TRAY BLOT GSD HS 3923 9000 | 10 PKG |
| 2020071814178 | Stadersand,Federal Republic of Germany -> Oakland, California | ON 10 PALLETS GSD-BD-50 TRAY BLOT GSD HS 3923 9000 | 10 PKG |
| 202003268160 | Stadersand,Federal Republic of Germany -> Oakland, California | ON 10 PALLETS GSD-BT-50 TRAY BLOT GSD HS 3923 9000 | 10 PKG |
| 2019103113178 | Stadersand,Federal Republic of Germany -> Oakland, California | ON 10 PALLETS PLASTIC TRAYS HS: 3923 9000 SHIPPED ON BOARD FREIGHT COLLECT | 10 PKG |
| 2019103010785 | Stadersand,Federal Republic of Germany -> Oakland, California | ON 10 PALLETS PLASTIC TRAYS HS: 3923 9000 SHIPPED ON BOARD FREIGHT COLLECT | 10 PKG |
| 2019080914460 | Stadersand,Federal Republic of Germany -> Oakland, California | TRAY BLOT GSD HS CODE 39239000 SCAC SSLL AMS REF OAK207626 | 8 PKG |
| 2019080627542 | Stadersand,Federal Republic of Germany -> Oakland, California | TRAY BLOT GSD HS CODE 39239000 SCAC SSLL AMS REF OAK207626 | 8 PKG |
| 2019010518842 | Stadersand,Federal Republic of Germany -> Oakland, California | GSD BT 50 TRAY BLOT GSD HS CODE 39239000 SCAC SSLL AMS-REF OAK207249 | 12 PKG |