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 Weizenkleie	37106906	EUDAMED	IVD General	Active
Allergen Discs Eiche	37220007	EUDAMED	IVD General	Active
Allergen Discs Lupinenmehl	37106339	EUDAMED	IVD General	Active
Allergen Discs Glaskraut (P. judaica)	37123021	EUDAMED	IVD General	Active
Allergen Discs Ahorn	37220001	EUDAMED	IVD General	Active
Allergen Discs Rotbarsch	37106056	EUDAMED	IVD General	Active
Allergen Discs Fusarium moniliforme	37113009	EUDAMED	IVD General	Active
Allergen Discs Pecannuss	37106103	EUDAMED	IVD General	Active
Allergen Discs Reis (roh)	37106009	EUDAMED	IVD General	Active
Allergen Discs Eschenholz	37111034	EUDAMED	IVD General	Active
Allergen Discs Tintenfisch	37106239	EUDAMED	IVD General	Active
Lineblot Ige Us8	ILE-LBL40	EUDAMED	IVD General	Active
Allergen Discs Spinat	37106038	EUDAMED	IVD General	Active
Allergen Discs Pen a 1 (Tropomyosin)	37124910	EUDAMED	IVD General	Active
Allergen Discs Wasserfloh (Cladocera)	37109074	EUDAMED	IVD General	Active
Allergen Discs Gummi arabicum	37106297	EUDAMED	IVD General	Active
Allergen Discs Kamille	37119902	EUDAMED	IVD General	Active
Allergen Discs Gerstenmehl	37106006	EUDAMED	IVD General	Active
Allergen Discs Kindernahrung	37236005	EUDAMED	IVD General	Active
Allergen Discs Mischung Tierepithelien I	37235901	EUDAMED	IVD General	Active
Allergen Discs Hühnerfleisch	37106083	EUDAMED	IVD General	Active
Allergen Discs Trimethoprim	37103202	EUDAMED	IVD General	Active
Allergen Discs Ziegenepithelien	37105080	EUDAMED	IVD General	Active
Allergen Discs Milch, gekocht	37106203	EUDAMED	IVD General	Active
Allergen Discs Amb a 1 (Ambrosie)	37124913	EUDAMED	IVD General	Active
Allergen Discs Haustiere	37235002	EUDAMED	IVD General	Active
Allergen Discs Macadamia-Nuss	37106345	EUDAMED	IVD General	Active
Allergen Discs Gräser-Getreide-Mix	37137902	EUDAMED	IVD General	Active
Allergen Discs Gänsedaunen	37105096	EUDAMED	IVD General	Active
Allergen Discs Weichhölzer	37241004	EUDAMED	IVD General	Active
Allergen Discs Isozyanat TDI	37111075	EUDAMED	IVD General	Active
Allergen Discs Narzisse	37123026	EUDAMED	IVD General	Active
Allergen Discs Schweineserumalbumin	37105204	EUDAMED	IVD General	Active
Allergen Discs Roggenmehl	37106005	EUDAMED	IVD General	Active
Allergen Discs r-Alt a 1 (Alternaria ten)	37124909	EUDAMED	IVD General	Active
Allergen Discs Goldrute	37123012	EUDAMED	IVD General	Active
Specific IgE ELISA (S Kit)	36070000	EUDAMED	IVD General	Active
Allergen Discs Chrysantheme	37223022	EUDAMED	IVD General	Active
Allergen Discs Tomate	37106025	EUDAMED	IVD General	Active
Allergen Discs Cashewnuss	37106105	EUDAMED	IVD General	Active
IgG4 Screen Nutritional TW22 ELISA	ILS-SCG140	EUDAMED	IVD General	Active
Allergen Discs Isozyanat HDI	37111077	EUDAMED	IVD General	Active
Allergen Discs Rosmarin	37119211	EUDAMED	IVD General	Active
Allergen Discs Aal	37106055	EUDAMED	IVD General	Active
Allergen Discs Schweineepithelien	37105083	EUDAMED	IVD General	Active
Allergen Discs Muskatnuß	37119005	EUDAMED	IVD General	Active
Allergen Discs r-Ole e1 (Olive)	37124926	EUDAMED	IVD General	Active
Allergen Discs Kamille (echte)	37123025	EUDAMED	IVD General	Active
Allergen Discs Wiesenfuchsschwanz	37207016	EUDAMED	IVD General	Active
Allergo Plus1 Igg4	ILE-SCG04	EUDAMED	IVD General	Active

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