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 Kümmel	37119003	EUDAMED	IVD General	Active
IgG4 Screen OMNI1	ILE-SCG902	EUDAMED	IVD General	Active
Allergen Discs Cephalosporine	37103201	EUDAMED	IVD General	Active
Allergen Discs Latex (Neotex FA (Film))	37111082	EUDAMED	IVD General	Active
Allergen Discs Seezunge	37106238	EUDAMED	IVD General	Active
Allergen Discs Fenchelsamen	37106219	EUDAMED	IVD General	Active
Allergen Discs Platane	37220011	EUDAMED	IVD General	Active
Allergen Discs Nahrungsmittel-Screening	37236903	EUDAMED	IVD General	Active
Allergen Discs Languste	37106071	EUDAMED	IVD General	Active
Allergen Discs Gluten/Gliadin	37106079	EUDAMED	IVD General	Active
Allergen Discs Raps	37123032	EUDAMED	IVD General	Active
Allergen Discs Mango	37106091	EUDAMED	IVD General	Active
immunoLINE IgG4 MX3	ILE-LBL13	EUDAMED	IVD General	Active
Allergen Discs Getreidestäube	37241003	EUDAMED	IVD General	Active
Allergen Discs Zeder	37120071	EUDAMED	IVD General	Active
Allergen Discs Curvularia lunata	37113016	EUDAMED	IVD General	Active
Allergen Discs r-Phl p 5 (Gräser)	37124902	EUDAMED	IVD General	Active
IgG / IgG4 Vorscreen OMNI	ILE-SCG901	EUDAMED	IVD General	Active
IgG Screen Nutritional 40 ELISA	ILE-SCG151	EUDAMED	IVD General	Active
Allergen Discs Löwenzahn	37223008	EUDAMED	IVD General	Active
Allergen Discs Synthetische Stoffe	37241001	EUDAMED	IVD General	Active
Allergen Discs Rote Mückenlarve	37109073	EUDAMED	IVD General	Active
Allergen Discs Cladosporium herbarum	37213002	EUDAMED	IVD General	Active
Allergen Discs Krebs	37106234	EUDAMED	IVD General	Active
Allergen Discs Ambrosie, ausdauernde	37223002	EUDAMED	IVD General	Active
Allergen Discs Bos d 4 (Alpha-Lactalbumin)	37124915	EUDAMED	IVD General	Active
Allergen Discs Papierwespe	37109904	EUDAMED	IVD General	Active
Allergen Discs Beifuß	37223006	EUDAMED	IVD General	Active
Allergen Discs Geflügel (Fleisch)	37236015	EUDAMED	IVD General	Active
Negativontrolle für ECP (Eosinophil Cationic protein) ELISA	36061003	EUDAMED	IVD General	Active
Allergen Discs Schimmelpilze II	37243002	EUDAMED	IVD General	Active
Allergen Discs CCD Bromelain	37124920	EUDAMED	IVD General	Active
Allergen Discs Phoma betae	37113013	EUDAMED	IVD General	Active
Allergen Discs Nectarine	37106162	EUDAMED	IVD General	Active
Allergen Discs Aspergillus fumigatus	37213003	EUDAMED	IVD General	Active
Allergen Discs Federmischung	37235071	EUDAMED	IVD General	Active
Allergen Discs Lachs	37106041	EUDAMED	IVD General	Active
Allergen Discs Schafwolle (unbearbeitet)	37111021	EUDAMED	IVD General	Active
Allergen Discs Tee (schwarz)	37106099	EUDAMED	IVD General	Active
Allergen Discs Amoxicillin	37103214	EUDAMED	IVD General	Active
Allergen Discs Wiesenlieschgras	37207006	EUDAMED	IVD General	Active
Allergen Discs Champignon	37106127	EUDAMED	IVD General	Active
Allergen Discs Stutenmilch	37106286	EUDAMED	IVD General	Active
Allergen Discs Sardelle	37106805	EUDAMED	IVD General	Active
Allergen Discs Rattenephitelien	37105073	EUDAMED	IVD General	Active
Allergen Discs Formaldehyd	37111080	EUDAMED	IVD General	Active
Allergen Discs Guarkernmehl	37106053	EUDAMED	IVD General	Active
Allergen Discs Zierfinkenfedern	37105050	EUDAMED	IVD General	Active
Allergen Discs Baumwolle (bearbeitet)	37111002	EUDAMED	IVD General	Active
Allergen Discs Lamm-/Hammelfleisch	37106088	EUDAMED	IVD General	Active

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