Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007208259

FEI Number

3007208259

Entity Name

GOLD STANDARD DIAGNOSTICS, LLC

City/State/Country

Davis, CA, US

Establishment Address

2795 2nd St Ste 300, Davis, CA 95618, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Gold Standard Diagnostics (Owner Number: 10025460)

Owner / Operator Contact Address

2795 2nd Street, Suite 300, Davis, CA 95618, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K970238

PMA Number

N/A

All Registered Proprietary Names

Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System Gold Standard Diagnostics Is-Mumps IgG ELISA Test Kit Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit Gold Standard Diagnostics Is-EBV-EA-D IgM Test Kit Gold Standard Diagnostics Is-Rubella IgG ELISA Test Kit Influenza B IgG ELISA Test Kit Influenza A IgG ELISA Test Kit Gold Standard Diagnostics Is-Rheumatoid Factor ELISA Test Kit Gold Standard Diagnostics Is-CMV IgG ELISA Test Kit HHV-6 IgG Sera Pack HHV-6 IgM Plates - Bulk HHV-6 IgM Sera Pack HHV-6 IgG Plates - Bulk Leishmania infantum Antigen Wells Leishmania infantum IgG Level 2 Serum Leishmania infantum IgG Level 1 Serum Leishmania infantum IgG Level 3 Serum Gold Standard Diagnostics Is-anti-Jo-1 ELISA Test Kit Gold Standard Diagnostics Is-anti-SS-A ELISA Test Kit Gold Standard Diagnostics Is-Anti-TG IgG ELISA Test Kit Gold Standard Diagnostics Is-ANA Screen ELISA Test Kit Strongyloides IgG ELISA Test Kit Trichinella spiralis IgG ELISA Test Kit HAILSTORM GSD Brucella IgG ELISA IgG Component Pack - Bulk IgM Component Pack - Bulk Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit Gold Standard Diagnostics Is-Anti-PR3 (C-ANCA) IgG ELISA Test Kit Gold Standard Diagnostics Is-EBNA-1 IgG ELISA Test Kit Gold Standard Diagnostics Is-anti-Scl-70 ELISA Test Kit Gold Standard Diagnostics Is-EBV-EA-D IgG Test Kit Gold Standard Diagnostics Is-EBV-VCA IgM Test Kit Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit Gold Standard Diagnostics Is-VZV IgG ELISA Test Kit Echinococcus IgG ELISA Test Kit Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC ELISA IgG/ IgM Test Kit Entamoeba histolytica IgG ELISA Test Kit Gold Standard Diagnostics Is-anti-dsDNA ELISA Test Kit Gold Standard Diagnostics Is-anti-SS-B ELISA Test Kit Gold Standard Diagnostics Is-EBV-VCA IgG Test Kit Gold Standard Diagnostics Is-anti-Sm ELISA Test Kit Gold Standard Diagnostics Is-anti-Sm/RNP ELISA Test Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GMQ	Antigens, Nontreponemal, All	Microbiology	Class 2	866.3820	2015-12-14
LJY	Enzyme Linked Immunoabsorbent Assay, Mumps Virus	Microbiology	Class 1	866.3380	2020-07-20
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2012-05-18
LSE	Epstein-Barr Virus, Other	Microbiology	Class 1	866.3235	2021-08-03
LFX	Enzyme Linked Immunoabsorbent Assay, Rubella	Microbiology	Class 2	866.3510	2020-07-13
GNW	Antisera, Cf, Influenza Virus A, B, C	Microbiology	Class 1	866.3330	2012-12-12
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2020-11-02
LFZ	Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus	Microbiology	Class 2	866.3175	2020-05-18
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2014-12-02
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2020-10-09
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2020-10-19
JZO	System, Test, Thyroid Autoantibody	Immunology	Class 2	866.5870	2020-09-04
LKJ	Antinuclear Antibody, Antigen, Control	Immunology	Class 2	866.5100	2025-02-24
MDT	Elisa, Trichinella Spiralis	Microbiology	Class 1	866.3850	2012-12-12
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2025-06-23
GSM	Antisera, Fluorescent, Brucella Spp.	Microbiology	Class 2	866.3085	2012-12-12
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2022-09-28
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2012-08-03
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2021-01-15
GNP	Antiserum, Cf, Epstein-Barr Virus	Microbiology	Class 1	866.3235	2021-04-23
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2020-06-29
GNP	Antiserum, Cf, Epstein-Barr Virus	Microbiology	Class 1	866.3235	2021-08-03
LSE	Epstein-Barr Virus, Other	Microbiology	Class 1	866.3235	2021-04-19
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2021-06-02
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2021-06-02
LFY	Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster	Microbiology	Class 2	866.3900	2020-05-18
GPF	Antigen, Agglutinating, Echinococcus Spp.	Microbiology	Class 1	866.3200	2012-12-12
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2020-04-24
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2021-05-04
KHW	Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.	Microbiology	Class 2	866.3220	2012-12-12
LRM	Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control	Immunology	Class 2	866.5100	2020-12-15
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2020-10-19
LSE	Epstein-Barr Virus, Other	Microbiology	Class 1	866.3235	2021-04-19
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2020-11-02
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2020-10-09

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Gold Standard Diagnostics

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3008191245	Gold Standard Diagnostics Frankfurt GmbH	Dietzenbach Hesse, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K873780	Labsystems, Inc.	MODIFICATION RUBELLA IGM EIA TEST KIT	1987-10-15
K181213	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control	2018-07-30
K000362	Zeus Scientific, Inc.	MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM	2000-02-18
K250250	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Anti-Thyroid Peroxidase II	2025-10-17
K152061	Siemens Healthcare Diagnostics, Inc.	IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material	2016-03-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0081-2017	Siemens Healthcare Diagnostics, Inc.	2	SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material Number (SMN) 10381282 (OUS), Unique Device Identification Number (UDI) 00630414964577; IVD --- For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2000 XPi Systems Analyzers-for the qualitative detection of IgM antibodies to Rubella virus in human serum or plasma (EDTA and heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age.
Z-0082-2017	Siemens Healthcare Diagnostics, Inc.	2	SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US: L2KRM2(D), Siemens Material Number (SMN) for US: 10374021, REF/Catalog # for OUS: L2KRM2, SMN for OUS: 10381327; Unique Device Identification Number (UDI) 00630414961996; IVD --- For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2000 XPi Systems Analyzers-for the qualitative detection of IgM antibodies to Rubella virus in human serum or plasma (EDTA and heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age
Z-0003-2013	Beckman Coulter Inc.	2	IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with the IMMAGE Immunochemistry System.
Z-0027-2018	Hologic, Inc	2	Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007208259. Last updated year: 2026. Please use registration number 3007208259 when referencing this establishment in official correspondence.