FDA Registration
Active
🇩🇪 Germany
Gold Standard Diagnostics Frankfurt GmbH
Reg #: 3008191245
·
FEI: 3008191245
·
Expires 2026
Products
8
Proprietary Names
13
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- Gold Standard Diagnostics Frankfurt GmbH
- Registration Number
- 3008191245
- FEI Number
- 3008191245
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Waldstrasse 23 A6
- City
- Dietzenbach Hesse
- Country
- DE
Owner / Operator
- Firm Name
- Gold Standard Diagnostics
- Operator Number
- 10031124
- Address
- Waldstrasse 23 A6
- City
- Dietzenbach
- State
- Hesse
- Postal Code
- 63128
- Country
- DE
- Correspondent
- Natalie J Kennel
US Agent
- Business Name
- NJK & Associates Inc
- Contact Name
- Natalie Kennel
- Address
- 13721 Via Tres Vis
- City
- San Diego
- State
- CA
- ZIP
- 92129
- Country
- US
- [email protected]
- Phone
- 858 7050350
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Antisera, Fluorescent, Brucella Spp. | GSM | Class 2 | Microbiology | No | 2017-05-20 |
| Elisa, Trichinella Spiralis | MDT | Class 1 | Microbiology | No | 2012-08-06 |
| Reagent, Borrelia Serological Reagent | LSR | Class 2 | Microbiology | No | 2024-12-31 |
| Antigen, Fluorescent Antibody Test, Schistosoma Mansoni | GNH | Class 1 | Microbiology | No | 2015-03-16 |
| Reagents, Cysticercosis | MDJ | Class 1 | Microbiology | No | 2012-08-13 |
| Antigen, Agglutinating, Echinococcus Spp. | GPF | Class 1 | Microbiology | No | 2012-08-06 |
| Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. | KHW | Class 2 | Microbiology | No | 2012-08-06 |
| Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. | LJZ | Class 1 | Microbiology | No | 2024-06-19 |
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 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
ENTG0140 Entamoeba histolytica IgG
Gold Standard Diagnostics Borrelia Burgdorferi Igm Blot Test
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device