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 Taubenserumprotein	37105013	EUDAMED	IVD General	Active
Allergen Discs Lorbeerblatt	37119004	EUDAMED	IVD General	Active
Allergen Discs Macoreholz	37111038	EUDAMED	IVD General	Active
IgG Screen Nutritional 44 IN ELISA	ILE-SCG115	EUDAMED	IVD General	Active
Positivkontrolle für Gesamt IgE ELISA	36216000	EUDAMED	IVD General	Active
Allergen Discs Ratte Epi.-Protein	37105087	EUDAMED	IVD General	Active
Tracer IgE	ILR-E01	EUDAMED	IVD General	Active
Specific IgE ELISA (XL Kit)	36080000	EUDAMED	IVD General	Active
Allergen Discs 6-Gräser (Allergopharma)	37237901	EUDAMED	IVD General	Active
Allergen Discs Art v 1 (Beifuß)	37124912	EUDAMED	IVD General	Active
Allergen Discs Gewürze II	37249002	EUDAMED	IVD General	Active
Allergen Discs Ampicillin	37103205	EUDAMED	IVD General	Active
Allergen Discs Liguster	37220020	EUDAMED	IVD General	Active
Allergen Discs Sonnenblumensamen	37111084	EUDAMED	IVD General	Active
Allergen Discs Parmesankäse	37106207	EUDAMED	IVD General	Active
Allergen Discs Aspergillus terreus	37113036	EUDAMED	IVD General	Active
Allergen Discs Aspergilli I	37243006	EUDAMED	IVD General	Active
Allergen Discs Oregano	37119009	EUDAMED	IVD General	Active
Allergen Discs Amarant (Fuchsschwanz)	37223014	EUDAMED	IVD General	Active
Allergen Discs Bohnen, grün	37106132	EUDAMED	IVD General	Active
Allergen Discs Mischung Nüsse	37236902	EUDAMED	IVD General	Active
Allergen Discs Esche	37220901	EUDAMED	IVD General	Active
Allergen Discs Trichoderma viride	37113015	EUDAMED	IVD General	Active
IgG Screen Nutritional BGR44 ELISA (20x Kit)	ILE-SCG130-20	EUDAMED	IVD General	Active
Allergen Discs Gewürze I	37249001	EUDAMED	IVD General	Active
Allergen Discs Kokosnuss	37106036	EUDAMED	IVD General	Active
Allergen Discs Ambrosie, falsche	37123004	EUDAMED	IVD General	Active
Allergen Discs Nordseegarnele	37106023	EUDAMED	IVD General	Active
Allergen Discs Wellensittichfedern	37105078	EUDAMED	IVD General	Active
Referenzreihe Spez. IgE	36120000	EUDAMED	IVD General	Active
Allergen Discs Gelatine (Schwein)	37106908	EUDAMED	IVD General	Active
Allergen Discs Bienengift (Apis mellifera)	37109001	EUDAMED	IVD General	Active
Allergen Discs Linde	37220027	EUDAMED	IVD General	Active
Allergen Discs Wiesenschwingel	37207004	EUDAMED	IVD General	Active
Allergen Discs Mandel	37106020	EUDAMED	IVD General	Active
Allergen Discs Beba HA	37106914	EUDAMED	IVD General	Active
Allergen Discs Ingwer	37119203	EUDAMED	IVD General	Active
Allergen Discs Zucchini	37106318	EUDAMED	IVD General	Active
Allergen Discs Birne	37106094	EUDAMED	IVD General	Active
Allergen Discs Kastanie	37120017	EUDAMED	IVD General	Active
Tetanus Toxid IgG ELISA	ILE-TET01	EUDAMED	IVD General	Active
Allergen Discs Insulin (human)	37103073	EUDAMED	IVD General	Active
IgG Screen Nutritional 24 ELISA	ILE-SCG150	EUDAMED	IVD General	Active
Allergen Discs Pinienkerne	37106808	EUDAMED	IVD General	Active
Allergen Discs Hundeepithelien	37205002	EUDAMED	IVD General	Active
Allergen Discs Ara h 2 (Erdnuss)	37124914	EUDAMED	IVD General	Active
Allergen Discs Brombeere	37106273	EUDAMED	IVD General	Active
Allergen Discs Meranti	37111047	EUDAMED	IVD General	Active
Allergen Discs Mucor racemosus	37113004	EUDAMED	IVD General	Active
Allergen Discs Sojabohne	37106014	EUDAMED	IVD General	Active

Gold Standard Diagnostics Kassel GmbH

What Gold Standard Diagnostics Kassel GmbH makes

Frequently asked questions

Information

Catalogue (571)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities