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
IgG4 Screen Nutritional 88 ELISA (20x Kit)	ILE-SCG80-20	EUDAMED	IVD General	Active
IgG Screen Select 6 ELISA	ILE-SCG67	EUDAMED	IVD General	Active
Allergen Discs Weizenschrot	37106260	EUDAMED	IVD General	Active
Allergen Discs Pistazie	37106104	EUDAMED	IVD General	Active
Allergen Discs Hummel (Bombus spp.)	37109008	EUDAMED	IVD General	Active
Allergen Discs Mucor mucedo	37113020	EUDAMED	IVD General	Active
Allergen Discs Sauerkirsche	37106280	EUDAMED	IVD General	Active
Allergen Discs Wermut	37123005	EUDAMED	IVD General	Active
Allergen Discs Weizendrusch	37111026	EUDAMED	IVD General	Active
Allergen Discs Selleriewurzel	37119901	EUDAMED	IVD General	Active
Allergen Discs Hühnerei (gelb)	37106075	EUDAMED	IVD General	Active
Allergen Discs Taubenfedern	37105011	EUDAMED	IVD General	Active
Allergen Discs Zwiebel	37106048	EUDAMED	IVD General	Active
Allergen Discs Primel	37123036	EUDAMED	IVD General	Active
Allergen Discs Wildseide	37111073	EUDAMED	IVD General	Active
Allergen Discs Candida albicans	37113005	EUDAMED	IVD General	Active
Allergen Discs Wellensittich-Serum	37105079	EUDAMED	IVD General	Active
Allergen Discs Gemüse I	37236006	EUDAMED	IVD General	Active
Allergen Discs Chaetomium globosum	37113045	EUDAMED	IVD General	Active
Allergen Discs Aspergillus nidulans	37113047	EUDAMED	IVD General	Active
Allergen Discs Karpfen	37106233	EUDAMED	IVD General	Active
Allergen Discs Tannenholz	37111044	EUDAMED	IVD General	Active
Allergen Discs Miesmuschel	37106037	EUDAMED	IVD General	Active
Allergen Discs Papageienfedern	37105010	EUDAMED	IVD General	Active
Allergen Discs Spermasediment	37115072	EUDAMED	IVD General	Active
Allergen Discs Feige	37106274	EUDAMED	IVD General	Active
Allergen Discs Malz	37106090	EUDAMED	IVD General	Active
Allergen Discs Back-/Bierhefe (Saccharomyces cer)	37106045	EUDAMED	IVD General	Active
Allergen Discs Honig	37106333	EUDAMED	IVD General	Active
Allergen Discs Helminthosporium halodes	37113008	EUDAMED	IVD General	Active
Allergen Discs Hirse	37106253	EUDAMED	IVD General	Active
Allergen Discs Papageienkot	37105098	EUDAMED	IVD General	Active
Allergen Discs Senf	37106089	EUDAMED	IVD General	Active
Allergen Discs Botrytis cinerea	37113007	EUDAMED	IVD General	Active
Allergen Discs Rhizopus nigricans	37113011	EUDAMED	IVD General	Active
Allergen Discs Cheddarkäse	37106081	EUDAMED	IVD General	Active
Allergen Discs Leinen	37111016	EUDAMED	IVD General	Active
Allergen Discs Ascaris	37116001	EUDAMED	IVD General	Active
Allergen Discs Aspergilli II	37243007	EUDAMED	IVD General	Active
Allergen Discs Edamer Käse	37106150	EUDAMED	IVD General	Active
Allergen Discs Kaninchenurinprotein	37165211	EUDAMED	IVD General	Active
Allergen Discs Leinsamenschrot	37106098	EUDAMED	IVD General	Active
Allergen Discs Ambrosie, beifußblättrige	37223001	EUDAMED	IVD General	Active
Allergen Discs Basilikum	37119010	EUDAMED	IVD General	Active
Allergen Discs Rose	37123028	EUDAMED	IVD General	Active
Allergen Discs Straußgras	37207901	EUDAMED	IVD General	Active
ECP (Eosinophil Cationic protein) ELISA	36061000	EUDAMED	IVD General	Active
Allergen Discs Inhalationsallergene	37238901	EUDAMED	IVD General	Active
Allergen Discs Phthalsäureanhydrid	37111079	EUDAMED	IVD General	Active
Allergen Discs Hasel	37220004	EUDAMED	IVD General	Active

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