Gold Standard Diagnostics Corp

FDA Filings

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.

FDA Registration(s)
Registration Number3007208259
FEI Number3007208259
NameGOLD STANDARD DIAGNOSTICS CORP.
Owner & OperatorGold Standard Diagnostics
Contact Address2851 spafford street
Davis CA 95618 US
Official Correspondent
  • Napoleon M Monce
  • x-530-7598000-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address2851 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



FDA Filings

Device
Company
DeviceDate
Gold Standard Diagnostics Corporation
Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System-5C GSD01-1600-5C2024-12-16
Gold Standard Diagnostics Corporation
Microtiterplates (5) GSD05-1600-MW2024-10-30
Gold Standard Diagnostics Corporation
Bolt 00500R2023-11-08
Gold Standard Diagnostics Corporation
Bolt (CLIA) 00500-CLR2023-11-08
Gold Standard Diagnostics Corporation
AIX1000 Analyzer 00400R2023-11-08
Gold Standard Diagnostics Corporation
ThunderBolt EIA 00300R2023-11-08
Gold Standard Diagnostics Corporation
ThunderBolt EIA (CLIA) 00300-CLR2023-11-08
Gold Standard Diagnostics Corporation
RPR Reactive Control GSD05-1600-PC2023-09-21
Gold Standard Diagnostics Corporation
RPR Non-Reactive Control GSD05-1600-NC2023-09-21
Gold Standard Diagnostics Corporation
Performance Check Dye Kit GSD01-24502023-09-21
Gold Standard Diagnostics Corporation
AIX1000 Performance Check Dye Kit GSD01-1600-DYE2023-09-21
Gold Standard Diagnostics Corporation
Leishmania infantum IgG Level 3 Serum GSD01-3006-L32023-03-23
Gold Standard Diagnostics Corporation
Leishmania infantum IgG Level 2 Serum GSD01-3006-L22023-03-23
Gold Standard Diagnostics Corporation
Leishmania infantum IgG Level 1 Serum GSD01-3006-L12023-03-23
Gold Standard Diagnostics Corporation
Leishmania infantum Antigen Wells GSD01-3006-AW2023-03-23
Gold Standard Diagnostics Corporation
HHV-6 IgM Sera Pack GSD05-1701-SP2022-12-15
Gold Standard Diagnostics Corporation
IgM Component Pack - Bulk GSD05-1701-CP2022-12-15
Gold Standard Diagnostics Corporation
HHV-6 IgM Plates - Bulk GSD05-1701-AW2022-12-15
Gold Standard Diagnostics Corporation
HHV-6 IgG Sera Pack GSD05-1700-SP2022-12-15
Gold Standard Diagnostics Corporation
Influenza A IgG ELISA Test Kit GSD01-30092022-12-15
Gold Standard Diagnostics Corporation
Echinococcus IgG ELISA Test Kit GSD01-30032022-12-15
Gold Standard Diagnostics Corporation
Gold Standard Diagnostics Is-EBV-EA-D IgM Test Kit 720-6502022-12-15
Gold Standard Diagnostics Corporation
Gold Standard Diagnostics Is-EBV-EA-D IgG Test Kit 720-6402022-12-15
Gold Standard Diagnostics Corporation
Gold Standard Diagnostics Is-EBNA-1 IgG ELISA Test Kit 720-6202022-12-15
Gold Standard Diagnostics Corporation
Gold Standard Diagnostics Is-EBV-VCA IgM Test Kit 720-6102022-12-15
Gold Standard Diagnostics Corporation
Gold Standard Diagnostics Is-EBV-VCA IgG Test Kit 720-6002022-12-15
Gold Standard Diagnostics Corporation
Gold Standard Diagnostics Is-Toxoplasma IgG ELISA Test Kit 720-3002022-12-13
Gold Standard Diagnostics Corporation
Gold Standard Diagnostics Is-anti-Jo-1 ELISA Test Kit 720-2902022-12-13
Gold Standard Diagnostics Corporation
Gold Standard Diagnostics Is-anti-Sm/RNP ELISA Test Kit 720-2702022-12-13
Gold Standard Diagnostics Corporation
Gold Standard Diagnostics Is-anti-SS-B ELISA Test Kit 720-2602022-12-13
Gold Standard Diagnostics Corporation
Gold Standard Diagnostics Is-anti-SS-A ELISA Test Kit 720-2502022-12-13
Gold Standard Diagnostics Corporation
Gold Standard Diagnostics Is-Rheumatoid Factor ELISA Test Kit 720-7102022-12-12
Gold Standard Diagnostics Corporation
Gold Standard Diagnostics Is-anti-dsDNA ELISA Test Kit 720-7002022-12-12
Gold Standard Diagnostics Corporation
Gold Standard Diagnostics Is-Anti-TG IgG ELISA Test Kit 720-4602022-12-12
Gold Standard Diagnostics Corporation
Gold Standard Diagnostics Is-Anti-TPO IgG ELISA Test Kit 720-4502022-12-12
Gold Standard Diagnostics Corporation
Gold Standard Diagnostics Is-Anti-PR3 (C-ANCA) IgG ELISA Test Kit 720-4402022-12-12
Gold Standard Diagnostics Corporation
Gold Standard Diagnostics Is-Anti-MPO (P-ANCA) IgG ELISA Test Kit 720-4302022-12-12
Gold Standard Diagnostics Corporation
Gold Standard Diagnostics Is-anti-Sm ELISA Test Kit 720-2402022-12-12
Gold Standard Diagnostics Corporation
GSD RPR Microtiterplate - 5 pack sleeve GSD05-1600-W2022-12-05
Gold Standard Diagnostics Corporation
Strongyloides IgG ELISA Test Kit GSD01-30122022-12-05
Gold Standard Diagnostics Corporation
Entamoeba histolytica IgG ELISA Test Kit GSD01-30132022-11-28
Gold Standard Diagnostics Corporation
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit GSD01-10312022-11-07
Gold Standard Diagnostics Corporation
IgM Reagent Pack GSD01-1002-RP2022-11-07
Gold Standard Diagnostics Corporation
Microtiterplates GSD-1600-W-CASE2022-10-24
Gold Standard Diagnostics Corporation
IgG Component Pack - Bulk GSD05-1700-CP2022-10-24
Gold Standard Diagnostics Corporation
Trichinella spiralis IgG ELISA Test Kit GSD01-30022022-10-24
Gold Standard Diagnostics Corporation
Toxocara canis IgG ELISA Test Kit GSD01-30012022-10-24
Gold Standard Diagnostics Corporation
HHV-6 IgG Plates - Bulk GSD05-1700-AW2022-10-17
Gold Standard Diagnostics Corporation
Influenza B IgG ELISA Test Kit GSD01-30102022-10-17
Gold Standard Diagnostics Corporation
SARS-CoV-2 IgA Sera Pack GSD01-1029-SP2022-10-17
Gold Standard Diagnostics Corporation
SARS-CoV-2 Component Pack GSD01-1029-CP2022-10-17
Gold Standard Diagnostics Corporation
H. pylori Component Pack GSD01-1002-HCP2022-10-17
Gold Standard Diagnostics Corporation
H. pylori IgM Sera Pack GSD01-1002-CP2022-10-17
Gold Standard Diagnostics Corporation
Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit GSD01-10262022-10-03
Gold Standard Diagnostics Corporation
Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit GSD01-10252022-10-03
Gold Standard Diagnostics Corporation
Bolt (CLIA) 00500CL2022-10-03
Gold Standard Diagnostics Corporation
Bolt 005002022-10-03
Gold Standard Diagnostics Corporation
ThunderBolt EIA (CLIA) 00300CL2022-10-03
Gold Standard Diagnostics Corporation
ThunderBolt EIA 003002022-10-03
Gold Standard Diagnostics Corporation
Gold Standard Diagnostics Borrelia burgdorferi VIsE-OspC ELISA IgG/ IgM Test Kit GSD01-10272021-07-28
Gold Standard Diagnostics Corporation
Gold Standard Diagnostics SARS-CoV-2 IgG ELISA Test Kit GSD01-10282021-06-04
Gold Standard Diagnostics Corporation
Gold Standard Diagnostics Is-Measles IgG ELISA Test Kit 720-5202021-06-04
Gold Standard Diagnostics Corporation
Gold Standard Diagnostics Is-VZV IgG ELISA Test Kit 720-3802021-06-04
GOLD STANDARD DIAGNOSTICS CORP.
Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit GSD01-10292021-01-12
GOLD STANDARD DIAGNOSTICS CORP.
Gold Standard Diagnostics Is-HSV 1&2 IgG ELISA Test Kit 720-3402020-09-07
GOLD STANDARD DIAGNOSTICS CORP.
Gold Standard Diagnostics Is-EBNA-1 IgM ELISA Test Kit 720-6302020-08-04
GOLD STANDARD DIAGNOSTICS CORP.
Gold Standard Diagnostics Is-Mumps IgG ELISA Test Kit 720-5402020-08-04
GOLD STANDARD DIAGNOSTICS CORP.
Gold Standard Diagnostics Is-Rubella IgG ELISA Test Kit 720-3602020-08-04
GOLD STANDARD DIAGNOSTICS CORP.
Gold Standard Diagnostics Is-anti-Scl-70 ELISA Test Kit 720-2802020-08-04
GOLD STANDARD DIAGNOSTICS CORP.
Gold Standard Diagnostics SARS-CoV-2 IgM ELISA Test Kit GSD01-10302020-07-28
GOLD STANDARD DIAGNOSTICS CORP.
Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit GSD01-10232020-07-09
GOLD STANDARD DIAGNOSTICS CORP.
Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit GSD01-10222020-07-09
GOLD STANDARD DIAGNOSTICS CORP.
Gold Standard Diagnostics Is-HSV 1&2 IgM ELISA Test Kit 720-3202020-06-11
GOLD STANDARD DIAGNOSTICS CORP.
Gold Standard Diagnostics Is-CMV IgG ELISA Test Kit 720-3202020-06-11
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 Kit2020-04-15
GOLD STANDARD DIAGNOSTICS CORP.
Gold Standard Diagnostics Borrelia burgdorferi B31 GSD10-10232018-07-06
GOLD STANDARD DIAGNOSTICS CORP.
Gold Standard Diagnostics Borrelia burgodorferi B3 GSD10-10222018-07-06
GOLD STANDARD DIAGNOSTICS CORP.
Gold Standard Diagnostics Borrelia burgdorferi B31 GSD04-10232018-07-06
GOLD STANDARD DIAGNOSTICS CORP.
Gold Standard Diagnostics Borrelia burgdorferi B31 GSD04-10222018-07-06
GOLD STANDARD DIAGNOSTICS CORP.
Gold Standard Diagnostics Borrelia burgodorferi Ig GSD10-10242018-07-06
GOLD STANDARD DIAGNOSTICS CORP.
Gold Standard Diagnostics Borrelia burgdorferi B31 GSD01-10192018-07-06
GOLD STANDARD DIAGNOSTICS CORP.
Gold Standard Diagnostics Borrelia burgodorferi B3 GSD01-10182018-07-06
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 Kit2018-05-15
GOLD STANDARD DIAGNOSTICS CORP.
Gold Standard Diagnostics RPR Reagent Pack GSD34-1600-R2018-03-29
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 GSD01-30072018-03-29
GOLD STANDARD DIAGNOSTICS CORP.
GSD Toxocara canis IgG ELISA GSD01-30002018-03-29
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 IgG2017-06-13
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]
Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System2015-12-14
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]
HHV-6 Serum Level 1, 2, 32014-12-02
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]
HHV-6 Antigen Wells2014-12-02
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]
H.pylori Serum Level 1, 2, 32014-12-02
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]
Gold Standard Diagnostics Antinuclear Antibody (ANA) Screen ELISA Test Kit2014-02-03
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]
Mumps IgG ELISA Kit2013-01-25
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]
GSD Trichinella Spiralis IgG ELISA Test Kit2012-12-12
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]
GSD Strongyloidies IgG ELISA Test2012-12-12
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]
GSD Entamoeba Histolytica ELISA Test Kit2012-12-12
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]
Brucella IgG ELISA2012-12-12
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]
GSD Echinococcus ELISA Test Kit2012-12-12
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]
Gold Standard Diagnostics Influenza B IgG ELISA Test2012-12-12
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]
Gold Standard Diagnostics Influenza A IgG ELISA Test2012-12-12
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]
Gold Standard Diagnostics Borrelia Burgdorferi B31 IgM Line2012-08-03
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]
Gold Standard Diagnostics Borrelia Burgdorferi B31 IgG Line Blot Test2012-05-18
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]
Gold Standard Diagnostics H. Pylori IgG ELISA Test Kit2012-05-18
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]
Thunderbolt EIA2012-05-18
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]
Thunderbolt EIA-CL2012-05-18
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]
Bolt EIA / EIA-CL2012-05-18
GOLD STANDARD DIAGNOSTICS CORP. [Gold Standard Diagnostics]
Gold Standard Diagnostics H. pylori IgA ELISA Test Kit2012-02-27

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