Gold Standard Diagnostics

FDA Filings

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:

FDA Registration(s)

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	Napoleon M Monce x-530-7598000-x
Registration Status	1
Initial Importer	Y
Registration Expiration	2020-04-25
Registration Address	2851 spafford street Davis, CA 95618 US
Establishment Type	Repack or Relabel Medical Device Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility

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	Napoleon M Monce x-530-7598000-x
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

FDA Filings

Device Company	Device	Date
PMN K203289 Gold Standard Diagnostics	Gold Standard Diagnostics Borrelia Burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit	2021-03-22
QKO 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
PMN K200025 Gold Standard Diagnostics	Gold Standard Diagnostics Borrelia Burgdorferi IgG ELISA Test Kit	2020-04-06
PMN K200023 Gold Standard Diagnostics	Gold Standard Diagnostics Borrelia Burgdorferi IgM ELISA Test Kit	2020-04-06
PMN K180264 \| LSR GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]	Gold Standard Diagnostics Borrelia borgdorferi IgG/IgM ELISA Test Kit	2018-05-15
PMN K180264 Gold Standard Diagnostics	Gold Standard Diagnostics Borrelia Burgdorferi IgG/IgM ELISA Test Kit	2018-05-02
MDJ GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]	Toxocara Canis IgG	2017-06-13
PMN K150358 \| GMQ GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]	Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System	2015-12-14
PMN K150358 GOLD STANDARD DIAGNOSTICS	Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System	2015-11-12
MVU GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]	HHV-6 Serum Level 1, 2, 3	2014-12-02
MVU GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]	HHV-6 Antigen Wells	2014-12-02
MVU GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]	H.pylori Serum Level 1, 2, 3	2014-12-02
PMN K131334 GOLD STANDARD DIAGNOSTICS	HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST	2014-02-28
PMN K131330 \| LJM GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]	Gold Standard Diagnostics Antinuclear Antibody (ANA) Screen ELISA Test Kit	2014-02-03
PMN K131330 GOLD STANDARD DIAGNOSTICS	GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT	2014-01-28
LJY GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]	Mumps IgG ELISA Kit	2013-01-25
MDT GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]	GSD Trichinella Spiralis IgG ELISA Test Kit	2012-12-12
MDT GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]	GSD Strongyloidies IgG ELISA Test	2012-12-12
KHW GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]	GSD Entamoeba Histolytica ELISA Test Kit	2012-12-12
GSM GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]	Brucella IgG ELISA	2012-12-12
GPF GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]	GSD Echinococcus ELISA Test Kit	2012-12-12
GNW GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]	Gold Standard Diagnostics Influenza B IgG ELISA Test	2012-12-12
GNW GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]	Gold Standard Diagnostics Influenza A IgG ELISA Test	2012-12-12
PMN K113846 \| LSR GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]	Gold Standard Diagnostics Borrelia Burgdorferi B31 IgM Line	2012-08-03
PMN K113846 GOLD STANDARD DIAGNOSTICS	BORRELIA BURGDORFERI IGM BLOT TEST	2012-06-01
PMN K113847 \| LSR GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]	Gold Standard Diagnostics Borrelia Burgdorferi B31 IgG Line Blot Test	2012-05-18
PMN K110745 \| LYR GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]	Gold Standard Diagnostics H. Pylori IgG ELISA Test Kit	2012-05-18
JJE GOLD STANDARD DIAGNOSTICS	Thunderbolt EIA	2012-05-18
JJE GOLD STANDARD DIAGNOSTICS	Thunderbolt EIA-CL	2012-05-18
JJE GOLD STANDARD DIAGNOSTICS	Bolt EIA / EIA-CL	2012-05-18
JJE GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]	Thunderbolt EIA	2012-05-18
JJE GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]	Thunderbolt EIA-CL	2012-05-18
JJE GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]	Bolt EIA / EIA-CL	2012-05-18
PMN K113847 GOLD STANDARD DIAGNOSTICS	BORRELIA BURGDORFERI IGG BLOT TEST	2012-04-11
PMN K110745 GOLD STANDARD DIAGNOSTICS	HELICOBACTER PYLORI ELISA IGG TEST KIT	2012-03-02
PMN K110899 \| LYR GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]	Gold Standard Diagnostics H. pylori IgA ELISA Test Kit	2012-02-27
PMN K110899 GOLD STANDARD DIAGNOSTICS	GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT	2012-02-01

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U.S. Import Records [external site]

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