37206002

Dénomination commerciale

non renseigné

Code d'IUD-ID

04260153752157

IUD-ID de base

B-04260153752157

Numéro de référence/catalogue

37206002

Entité d'attribution

GS1

Catégorie de risque

IVDD — Général

Législation applicable

IVDD [Directive 98/79/CE relative aux dispositifs médicaux de diagnostic in vitro]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The Gold Standard Diagnostics Kassel Spez. IgE test system is a paper disc-based enzyme immunoassay for the quantitative detection of allergen specific IgE antibodies against various allergens in human serum and plasma. It is composed of Gold Standard Diagnostics Kassel Spez. IgE kits (Spez. IgE S and XL) and Gold Standard Diagnostics Kassel Spez. IgE Discs (available for various allergens) which can only be used in combination and need to be ordered separately. The Spez. IgE test system is intended for in vitro diagnostic use as an aid in the diagnostic evaluation of patients with proven or suspected IgE-mediated allergic disorders. It is designed for manual processing by professional users experienced in the use of in vitro diagnostic methods (e.g., laboratory qualified personnel). Specific IgE results should always be used in combination with other clinical findings such as the patient history and further tests like skin prick tests and - if possible - provocation tests. Positive and negative specific IgE results cannot predict or rule out a future anaphylactic reaction to a specific allergen.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• W01020202IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT

Aucun certificat ne référence l'IUD-ID de base de ce dispositif.