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 Mehlmischung	37236901	EUDAMED	IVD General	Active
Allergen Discs Der p 1 (Der. pter.)	37124904	EUDAMED	IVD General	Active
Allergen Discs Gal d1 Ovomucoid	37124918	EUDAMED	IVD General	Active
Allergen Discs Blaubeere	37106272	EUDAMED	IVD General	Active
Lineblot Ige Us6	ILE-LBL38	EUDAMED	IVD General	Active
Allergen Discs Gräser (frühblühend)	37237001	EUDAMED	IVD General	Active
Allergen Discs Reismehlkäfer (T. confusum)	37109009	EUDAMED	IVD General	Active
Allergen Discs Nymphensittichfedern	37105207	EUDAMED	IVD General	Active
Allergen Discs Pfeffer	37119007	EUDAMED	IVD General	Active
immunoLINE IgG4 Nutritional	ILE-LBL10	EUDAMED	IVD General	Active
Allergen Discs Schellfisch	37106042	EUDAMED	IVD General	Active
Allergen Discs Aspergillus amstelodami	37113040	EUDAMED	IVD General	Active
Allergen Discs Petersilie	37106086	EUDAMED	IVD General	Active
Allergen Discs Alternaria tenuis	37113006	EUDAMED	IVD General	Active
Allergen Discs Bäume (frühblühend)	37250005	EUDAMED	IVD General	Active
IgG Screen Select 4 ELISA	ILE-SCG65	EUDAMED	IVD General	Active
Allergen Discs Bet. v1 (Birke)	37124901	EUDAMED	IVD General	Active
Allergen Discs Nutztiere	37235003	EUDAMED	IVD General	Active
RF-Absorbens	ILE-MJS02	EUDAMED	IVD General	Active
Allergen Discs Hummer	37106080	EUDAMED	IVD General	Active
Allergen Discs Gänsefleisch	37106058	EUDAMED	IVD General	Active
Allergen Discs Kokosflocken	37106257	EUDAMED	IVD General	Active
Allergen Discs Kanarienvogelfedern	37105009	EUDAMED	IVD General	Active
Allergen Discs Blumen II	372506	EUDAMED	IVD General	Active
Allergen Discs Gänsefuß, weißer	37223010	EUDAMED	IVD General	Active
Allergen Discs Ananas	37106072	EUDAMED	IVD General	Active
Allergen Discs Pflaume	37106122	EUDAMED	IVD General	Active
Allergen Discs Kiwi	37106084	EUDAMED	IVD General	Active
Allergen Discs Roggen	37207012	EUDAMED	IVD General	Active
Allergen Discs Ziegenkäse	37106209	EUDAMED	IVD General	Active
Allergen Discs Bremse (Tabanus spp.)	37109004	EUDAMED	IVD General	Active
Allergen Discs Rattenkot	37105090	EUDAMED	IVD General	Active
Allergen Discs Fischfutter Daphnia	37115204	EUDAMED	IVD General	Active
Screen Igg4	ILE-SCG01	EUDAMED	IVD General	Active
Allergen Discs Artischocke	37106319	EUDAMED	IVD General	Active
Allergen Discs Furosemid	37103210	EUDAMED	IVD General	Active
Allergen Discs Olive	37120009	EUDAMED	IVD General	Active
Allergen Discs Mischung Schimmelpilze I	37243901	EUDAMED	IVD General	Active
Allergen Discs Pappel	37220014	EUDAMED	IVD General	Active
Allergen Discs Gurke	37106133	EUDAMED	IVD General	Active
immunoLINE IgE Atopic	ILE-LBL23	EUDAMED	IVD General	Active
Allergen Discs r-Ves V1 (Wespe)	37124924	EUDAMED	IVD General	Active
Allergen Discs Gerstenkleie	37106903	EUDAMED	IVD General	Active
Allergen Discs Mischung Schimmelpilze III	37243903	EUDAMED	IVD General	Active
Allergen Discs Knäuelgras, gemeines	37207003	EUDAMED	IVD General	Active
Allergen Discs Kardamom	37106267	EUDAMED	IVD General	Active
IgG Screen Nutritional 24 ET ELISA	ILE-SCG107	EUDAMED	IVD General	Active
Allergen Discs Flieder	37220021	EUDAMED	IVD General	Active
Allergen Discs Haselnuss	37106017	EUDAMED	IVD General	Active
Allergen Discs Johannisbeere	37106276	EUDAMED	IVD General	Active

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