Gold Standard Diagnostics Kassel GmbH
DE-MF-000021646 · Germany · Kassel
Gold Standard Diagnostics Kassel GmbH is registered in the European database on medical devices as a manufacturer, with 573 devices declared. It has a similarly named entry in the FDA register that we have not verified.
What this manufacturer declares
Most frequent device types declared: Allergen Discs Pferdeepithelien.
Devices declared under this manufacturer
- IgG Screen Nutritional 88 ELISA (20x Kit)
- IgG Screen Nutritional BGR40 ELISA
- IgG Screen Nutritional BGR44 ELISA
- IgG Screen OMNI3
- IgG4 Screen Nutritional 88 ELISA (20x Kit)
- IgG4 Screen OMNI1
- IgG4 Screen OMNI3
- Kontrollallergenscheiben für Spez. IgE ELISA
- Positivkontrolle für Spez. IgE ELISA
- Specific IgE ELISA (S Kit)
- Specific IgE RIA
- immunoLINE IgE Nutritional KW2
Showing 12 of 573 declared devices.
Catalogue references include 37106103, 37106130, 37106206, 37106252, 37106312, 37113013.
European nomenclature codes declared: W01020202, W01020208, W01020203, W01020205, W01020201, W0102019099.
United States market access
| FDA establishment register | Similar name found — unverified |
|---|---|
| Matched entry | GOLD STANDARD DIAGNOSTICS, LLC (US) · FDA 3007208259 |
| Devices in EUDAMED | 573 |
| Country of registration | Germany |
⚠️ A similar name exists; we do not assert it is the same company — why.
Device-level evidence
| Devices with a numeric GTIN | 535 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Similar name found — unverified |
|---|---|
| Matched entry | GOLD STANDARD DIAGNOSTICS, LLC |
⚠️ A similar name exists; unverified — why.
What it holds in Canada
| Licences on record | 12 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 11 |
| Class 3 devices | 1 |
| First licensed | 2016-08-31 |
Licence types: Test Kit (8), Single Device (2), System (1), Device Family (1).
Licensed under: THUNDERBOLT EIA, AIX1000 RAPID PLASMA REAGIN (RPR) AUTOMATED TE, BORRELIA BURGDORFERI B31 IGG LINE BLOT TEST KI, BORRELIA BURGDORFERI B31 IGM LINE BLOT TEST KI, GOLD STANDARD DIAGNOSTICS BORRELIA BURGDORFERI, GOLD STANDARD DIAGNOSTICS BORRELIA BURGDORFERI.