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 Kefir	37106206	EUDAMED	IVD General	Active
Allergen Discs Pfirsich	37106095	EUDAMED	IVD General	Active
Allergen Discs Gemüse III	37236008	EUDAMED	IVD General	Active
Allergen Discs Sardine	37106237	EUDAMED	IVD General	Active
Allergen Discs Reis, Langkorn, gekocht	37106918	EUDAMED	IVD General	Active
Allergen Discs Sadebaum	37120006	EUDAMED	IVD General	Active
Allergen Discs Tabakstaub	37111024	EUDAMED	IVD General	Active
Allergen Discs Stoffe/Fasern	37241002	EUDAMED	IVD General	Active
Allergen Discs Kakao	37106093	EUDAMED	IVD General	Active
Allergen Discs Tyrophagus putrescentiae	37104072	EUDAMED	IVD General	Active
IgG4 Screen OMNI3	ILE-SCG906	EUDAMED	IVD General	Active
Allergo Plus2 Igg4	ILE-SCG05	EUDAMED	IVD General	Active
Allergen Discs Kohl	37601039	EUDAMED	IVD General	Active
Helicobacter pylori IgA ELISA	ILE-HEL02	EUDAMED	IVD General	Active
Allergen Discs Hausstaub	37208004	EUDAMED	IVD General	Active
Allergen Discs Banane	37106092	EUDAMED	IVD General	Active
Allergen Discs Rinderepithelien	37205004	EUDAMED	IVD General	Active
Allergen Discs Venusmuschel	37106101	EUDAMED	IVD General	Active
Positivkontrolle für ECP (Eosinophil Cationic protein) ELISA	36061002	EUDAMED	IVD General	Active
IgG4 Screen Nutritional TW88 ELISA	ILE-SCG141	EUDAMED	IVD General	Active
Allergen Discs Maismehl	37106008	EUDAMED	IVD General	Active

Gold Standard Diagnostics Kassel GmbH

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