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
37205003	37205003	EUDAMED	IVD General	Active
Allergen Discs Radieschen	37106309	EUDAMED	IVD General	Active
Allergen Discs Cerealien/Mehle	37236003	EUDAMED	IVD General	Active
Allergen Discs Pfefferminz-Kräuter	37106126	EUDAMED	IVD General	Active
Allergen Discs Schweizer Käse	37106070	EUDAMED	IVD General	Active
Allergen Discs Mischung Federn	37135903	EUDAMED	IVD General	Active
Allergen Discs Pferdefliege	37109201	EUDAMED	IVD General	Active
Allergen Discs Chymopapain	37103003	EUDAMED	IVD General	Active
Allergen Discs HSA (Humanserumalbumin)	37111905	EUDAMED	IVD General	Active
IgG Screen Nutritional BGR44 ELISA	ILE-SCG130	EUDAMED	IVD General	Active
Allergen Discs Broccoli	37106134	EUDAMED	IVD General	Active
Allergen Discs Dermatophag. farinae	37204002	EUDAMED	IVD General	Active
Allergen Discs Wildschweinfleisch	37106222	EUDAMED	IVD General	Active
Allergen Discs Wassermelone	37106087	EUDAMED	IVD General	Active
Allergen Discs Mischung Tierhaare II	37105902	EUDAMED	IVD General	Active
Allergen Discs Aptamil	37106915	EUDAMED	IVD General	Active
Allergen Discs Käfigvögelmischung	37235072	EUDAMED	IVD General	Active
Allergen Discs r-Bet v 2 (Birke)	37124907	EUDAMED	IVD General	Active
Allergen Discs Margerite	37223007	EUDAMED	IVD General	Active
Allergen Discs Dinkel	37106251	EUDAMED	IVD General	Active
Allergen Discs Lakritz	37111263	EUDAMED	IVD General	Active
Allergen Discs Schilfrohr	37207007	EUDAMED	IVD General	Active
Allergen Discs Teakholz	37111045	EUDAMED	IVD General	Active
Allergen Discs Avocado	37106096	EUDAMED	IVD General	Active
Allergen Discs Vanille	37119012	EUDAMED	IVD General	Active
Allergen Discs Makrele	37106235	EUDAMED	IVD General	Active
Allergen Discs Dreschstaub	37111004	EUDAMED	IVD General	Active
Allergen Discs Erbse	37106012	EUDAMED	IVD General	Active
Allergen Discs Kopfsalat	37106100	EUDAMED	IVD General	Active
Allergen Discs Rote Bete	37106136	EUDAMED	IVD General	Active
Allergen Discs Blumenkohl, roh	37106062	EUDAMED	IVD General	Active
immunoLINE IgG4 MX2	ILI-LBL12	EUDAMED	IVD General	Active
Allergen Discs Thymian	37119212	EUDAMED	IVD General	Active
Allergen Discs Gummi tragant	37106298	EUDAMED	IVD General	Active
Allergen Discs Penicillin G	37103001	EUDAMED	IVD General	Active
IgG Screen Nutritional BGR40 ELISA	ILE-SCG131	EUDAMED	IVD General	Active
Allergen Discs Schwarze Olive	37106131	EUDAMED	IVD General	Active
Allergen Discs Bäume-Mischung	37290902	EUDAMED	IVD General	Active
Allergen Discs Majoran	37119206	EUDAMED	IVD General	Active
Allergen Discs Maisgemüse	3710121	EUDAMED	IVD General	Active
Allergen Discs Forelle	37106022	EUDAMED	IVD General	Active
Allergen Discs Anis	37119001	EUDAMED	IVD General	Active
Allergen Discs Fischfutter Tetramin	37115203	EUDAMED	IVD General	Active
Allergen Discs Maus Epi.-Protein	37105088	EUDAMED	IVD General	Active
Specific IgE RIA	ILR-E02	EUDAMED	IVD General	Active
Allergen Discs Penicillia	37243008	EUDAMED	IVD General	Active
immunoLINE IgE Nutritional KW1	ILE-LBL35	EUDAMED	IVD General	Active
Allergen Discs Grapefruit	37106030	EUDAMED	IVD General	Active
Allergen Discs Wellensittich-Kot	37105077	EUDAMED	IVD General	Active
Allergen Discs Weizenmehl	37106004	EUDAMED	IVD General	Active

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