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 Hornissengift (V. crabro)	37109075	EUDAMED	IVD General	Active
Allergen Discs Schimmelkäse	37106082	EUDAMED	IVD General	Active
Allergen Discs Estragon	37106809	EUDAMED	IVD General	Active
Allergen Discs Paranuss	37106018	EUDAMED	IVD General	Active
Allergen Discs Mohn	37119207	EUDAMED	IVD General	Active
Allergen Discs Nüsse	37236001	EUDAMED	IVD General	Active
Allergen Discs Mäuse-Urinprotein	37105072	EUDAMED	IVD General	Active
IgG Screen Nutritional 88 ELISA (20x Kit)	ILE-SCG26-20	EUDAMED	IVD General	Active
Helicobacter pylori IgM ELISA	ILE-HEL03	EUDAMED	IVD General	Active
Allergen Discs Roggenkleie	37106905	EUDAMED	IVD General	Active
Allergen Discs Zypresse	37120023	EUDAMED	IVD General	Active
Allergen Discs r-Pla I 1 (Wegerich)	37124006	EUDAMED	IVD General	Active
Allergen Discs Kuhmilcheiweiß	37206002	EUDAMED	IVD General	Active
Allergen Discs Heustaub	37111007	EUDAMED	IVD General	Active
Allergen Discs Buchweizenmehl	37106011	EUDAMED	IVD General	Active
Allergen Discs Paprika (Gewürz)	37119006	EUDAMED	IVD General	Active
Allergen Discs Thunfisch	37106040	EUDAMED	IVD General	Active
Allergen Discs Fichte	37220902	EUDAMED	IVD General	Active
Allergen Discs Mais	37207020	EUDAMED	IVD General	Active
Allergen Discs Nymphensittich-Kot	37105091	EUDAMED	IVD General	Active
Allergen Discs Alkalase	37111270	EUDAMED	IVD General	Active
Allergen Discs Karotte	37106031	EUDAMED	IVD General	Active
Allergen Discs Goldhamsterepithelien	37105084	EUDAMED	IVD General	Active
Allergen Discs Schweinefleisch	37106026	EUDAMED	IVD General	Active
IgG Screen OMNI3	ILE-SCG907	EUDAMED	IVD General	Active
Allergen Discs Kartoffel	37106035	EUDAMED	IVD General	Active
Allergen Discs Papaya	37106293	EUDAMED	IVD General	Active
Allergen Discs Apfelsine (Orange)	37106033	EUDAMED	IVD General	Active
Allergen Discs Hyazinthe	37123040	EUDAMED	IVD General	Active
Allergen Discs Esskastanie	37106019	EUDAMED	IVD General	Active
Gliadin IgM ELISA	ILE-GLI03	EUDAMED	IVD General	Active
Allergen Discs Rinderserumalbumin	37105212	EUDAMED	IVD General	Active
Allergen Discs Muttermilch	37106204	EUDAMED	IVD General	Active
Allergen Discs Kirsche	37106073	EUDAMED	IVD General	Active
immunoLINE IgE Perennial	ILE-LBL22	EUDAMED	IVD General	Active
Allergen Discs Car p 1 Papain	37124922	EUDAMED	IVD General	Active
Allergen Discs Pfeffer, grün	37106263	EUDAMED	IVD General	Active
Diphtheria Toxid IgG ELISA	ILE-DIP01	EUDAMED	IVD General	Active
Allergen Discs Paracetamol/Phenacetin	37103209	EUDAMED	IVD General	Active
Allergen Discs Hainbuche	37220903	EUDAMED	IVD General	Active
Allergen Discs Johanniskernmehl	37106255	EUDAMED	IVD General	Active
Allergen Discs r-Ves V5 (Wespe)	37124925	EUDAMED	IVD General	Active
Allergen Discs Paprika (Gemüse)	37106046	EUDAMED	IVD General	Active
Allergen Discs Robinie	37220028	EUDAMED	IVD General	Active
Allergen Discs Fischfutter Artemia Salina	37115202	EUDAMED	IVD General	Active
Allergen Discs Feuerameise (Solenop. spp)	37109070	EUDAMED	IVD General	Active
Allergen Discs Porree	37106066	EUDAMED	IVD General	Active
Allergen Discs Nagermischung	37235070	EUDAMED	IVD General	Active
Allergen Discs Pullularia pullulans	37113902	EUDAMED	IVD General	Active
Allergen Discs Gal d2 Ovalbumin	37124919	EUDAMED	IVD General	Active

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