Gold Standard Diagnostics Frankfurt GmbH
DE-MF-000025020 · Germany · Dietzenbach
Gold Standard Diagnostics Frankfurt GmbH is registered in the European database on medical devices as a manufacturer, with 420 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Devices declared under this manufacturer
- Citrat Stopplösung/Stopping Solution ELISA
- IgA 2 Konjugat/Conjugate (anti-human) ELISA
- IgA Konjugat/Conjugate (anti-human) ELISA
- IgA Konjugat/Conjugate (anti-human) LINE
- IgG Konjugat/Conjugate (anti-human) ELISA
- IgG Konjugat/Conjugate (anti-human) LINE
- IgM Konjugat/Conjugate (anti-human) ELISA
- IgM Konjugat/Conjugate (anti-human) LINE
- PBS-Verdünnungspuffer/Dilution Buffer ELISA
- PBS-Waschlösung/Washing Solution ELISA
- RF-SorboTech
- Substrat/Substrate LINE
Showing 12 of 420 declared devices.
Catalogue references include CHIM0590, DEHSV2M0540, HSV1G0500, MAL0620DS, RE58641, RE58711.
European nomenclature codes declared: W0105040604, W0105900201, W0105050299, W0105011707, W0105011703, W0105040611.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Gold Standard Diagnostics Frankfurt GmbH (DE) · FDA 3008191245 |
| Devices in EUDAMED | 420 |
| Country of registration | Germany |
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.