Question 1

What does Gold Standard Diagnostics Kassel GmbH manufacture?

Accepted Answer

Gold Standard Diagnostics Kassel GmbH manufactures in vitro diagnostic (IVD) test kits, including ELISA-based assays for detecting IgG4 and IgG antibodies related to nutritional sensitivities, such as the IgG4 Screen Nutritional 88 ELISA and IgG Screen Select 6 ELISA. The company also produces allergen discs for specific substances, including various food items like wheat, pistachio, cherry, and egg yolk, as well as environmental allergens such as bee venom, mold (Mucor mucedo), mugwort, and pigeon feathers.

These devices are classified as IVD General under the EU regulatory framework and are listed in the Eudamed database. The manufacturer is based in Germany (DE).

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Question 2

Where is Gold Standard Diagnostics Kassel GmbH based?

Accepted Answer

Gold Standard Diagnostics Kassel GmbH is based in Germany, as indicated by the country code DE in the provided data. The company’s location is specified within the device data summary, which states the manufacturer is based in Germany (DE).

Question 3

In which regulatory registry are the devices of Gold Standard Diagnostics Kassel GmbH listed?

Accepted Answer

The devices manufactured by Gold Standard Diagnostics Kassel GmbH are listed in the Eudamed database, which is the European Union’s medical device and in vitro diagnostic regulatory registry. This is explicitly stated in the device data under 'LISTED IN: eudamed'.

Question 4

How are the devices of Gold Standard Diagnostics Kassel GmbH classified under EU regulations?

Accepted Answer

The devices manufactured by Gold Standard Diagnostics Kassel GmbH are classified as IVD General under the EU regulatory framework for in vitro diagnostic medical devices. This classification is specified in the device data under 'DEVICE CLASSES: IVD General' and confirmed in the summary, which states these devices are classified as IVD General.

Device	Model / Reference	Registries	Class	Status
Allergen Discs Gummibärchen	37106801	EUDAMED	IVD General	Active
IgG4 Screen Nutritional 88 ELISA	ILE-SCG80	EUDAMED	IVD General	Active
Allergen Discs Blumen I	37253005	EUDAMED	IVD General	Active
Allergen Discs Chinichillaepithelien	37105203	EUDAMED	IVD General	Active
Allergen Discs Insulin (Rind)	37103071	EUDAMED	IVD General	Active
IgG4 Screen OMNI2	ILE-SCG904	EUDAMED	IVD General	Active
Allergen Discs Bos d 5 (Beta-Lactoglobulin)	37124916	EUDAMED	IVD General	Active
Allergen Discs Dill	37119011	EUDAMED	IVD General	Active
Allergen Discs Aubergine	37106301	EUDAMED	IVD General	Active
Allergen Discs Lysozym	37111208	EUDAMED	IVD General	Active
Allergen Discs Honiggras, wolliges	37207013	EUDAMED	IVD General	Active
Allergen Discs Taubenzecke	37109901	EUDAMED	IVD General	Active
Allergen Discs Mäusekot	37105089	EUDAMED	IVD General	Active
Allergen Discs Putenfleisch	37106130	EUDAMED	IVD General	Active
Allergen Discs Entenfedern	37105086	EUDAMED	IVD General	Active
Allergen Discs Seide	37111022	EUDAMED	IVD General	Active
Allergen Discs Curry	37119002	EUDAMED	IVD General	Active
Allergen Discs Humana S.L.	37106917	EUDAMED	IVD General	Active
Allergen Discs Backhilfsmittel	37106332	EUDAMED	IVD General	Active
Allergen Discs Zitrone	37106032	EUDAMED	IVD General	Active
Allergen Discs Euroglyphus maynei	37104074	EUDAMED	IVD General	Active
Allergen Discs Bos d 8 (Casein)	37124917	EUDAMED	IVD General	Active
Allergen Discs Eichenholz	37111033	EUDAMED	IVD General	Active
Allergen Discs Walnuss	37106016	EUDAMED	IVD General	Active
Allergen Discs Milbenmischung	37238002	EUDAMED	IVD General	Active
Allergen Discs Blumenkohl, gekocht	37106061	EUDAMED	IVD General	Active
Allergen Discs Acarus siro	37104070	EUDAMED	IVD General	Active
Fintest Igg4 (90) Korea	ILE-SCG220	EUDAMED	IVD General	Active
Allergen Discs Entendaunen	37105095	EUDAMED	IVD General	Active
IgG4 Screen Nutritional I 2 90 ELISA	ILE-SCG211	EUDAMED	IVD General	Active
Allergen Discs Kiefer	37220016	EUDAMED	IVD General	Active
Allergen Discs Dermatophag. microceras	37104003	EUDAMED	IVD General	Active
Allergen Discs Ficus spec.	37111081	EUDAMED	IVD General	Active
Allergen Discs Bettfedern	37235005	EUDAMED	IVD General	Active
Allergen Discs Pyrazolon	37103208	EUDAMED	IVD General	Active
Allergen Discs Aspergillus niger	37113033	EUDAMED	IVD General	Active
Allergen Discs Hering	37106021	EUDAMED	IVD General	Active
Allergen Discs Hopfen	37223902	EUDAMED	IVD General	Active
Allergen Discs Fleisch	37236004	EUDAMED	IVD General	Active
Allergen Discs Gouda Käse	37106201	EUDAMED	IVD General	Active
Allergen Discs Himbeere	37106275	EUDAMED	IVD General	Active
Allergen Discs Eukalyptus	37120018	EUDAMED	IVD General	Active
Allergen Discs Linse	37106065	EUDAMED	IVD General	Active
Allergen Discs Erdnuss	37106013	EUDAMED	IVD General	Active
Allergen Discs Entenfleisch	37106057	EUDAMED	IVD General	Active
Allergen Discs Mischung Schimmelpilze II	37243902	EUDAMED	IVD General	Active
Allergen Discs Heilbutt	37106902	EUDAMED	IVD General	Active
Allergen Discs Cladosporium cladospor	37113032	EUDAMED	IVD General	Active
Allergen Discs Brennessel	37223020	EUDAMED	IVD General	Active
Allergen Discs Hühnerei (gesamt)	37106074	EUDAMED	IVD General	Active

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