Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008191245

FEI Number

3008191245

Entity Name

Gold Standard Diagnostics Frankfurt GmbH

City/State/Country

Dietzenbach Hesse, DE

Establishment Address

Waldstrasse 23 A6, Dietzenbach Hesse 63128, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Gold Standard Diagnostics (Owner Number: 10031124)

Owner / Operator Contact Address

Waldstrasse 23 A6, Dietzenbach, DE-HE 63128, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TRIG0480 Trichinella spiralis IgG Strongyloides IgG ELISA test Gold Standard Diagnostics Borrelia Burgdorferi Igm ELISA Test Kit Gold Standard Diagnostics Borrelia Burgdorferi Igg Blot test Gold Standard Diagnostics Borrelia Burgdorferi Igg/Igm ELISA Test Kit NovaLisa (TM) Schistosoma mansoni IgG Elisa Gold Standard Diagnostics Borrelia Burgdorferi Igm ELISA Test Kit Gold Standard Diagnostics Borrelia Burgdorferi Igg ELISA Test Kit Gold Standard Diagnostics Borrelia Burgdorferi VlsE-OspC Igg/Igm ELISA Test Kit TOCG0450 Toxocara canis IgG TAEG0450 Taenia solium IgG ECHG0130 Echinococcus IgG

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GSM	Antisera, Fluorescent, Brucella Spp.	Microbiology	Class 2	866.3085	2017-05-20
MDT	Elisa, Trichinella Spiralis	Microbiology	Class 1	866.3850	2012-08-06
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2024-12-31
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2024-12-31
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2024-12-31
GNH	Antigen, Fluorescent Antibody Test, Schistosoma Mansoni	Microbiology	Class 1	866.3600	2015-03-16
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2024-12-31
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2024-12-31
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2024-12-31
MDJ	Reagents, Cysticercosis	Microbiology	Class 1	866.3200	2012-08-13
GPF	Antigen, Agglutinating, Echinococcus Spp.	Microbiology	Class 1	866.3200	2012-08-06

Official Correspondent

Natalie Kennel

US Agent Details

Natalie Kennel Business: NJK & Associates Inc Email: nkennel@njkconsulting.com Phone: (858) 7050350

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
3007208259	GOLD STANDARD DIAGNOSTICS, LLC	Davis, CA, US

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3003268355	EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG	Luebeck Schleswig-Holstein, DE
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008191245. Last updated year: 2026. Please use registration number 3008191245 when referencing this establishment in official correspondence.