RE51021

Nom de l'organisation

IBL International GmbH

SRN

DE-MF-000015709

Statut du fabricant

Actif

3 avertissements enregistrés — faire défiler le panneau pour tout voir.

• CW010

  EUDAMED n'a pas publié de description pour ce code.
• CW266

  EUDAMED n'a pas publié de description pour ce code.
• CW267

  EUDAMED n'a pas publié de description pour ce code.

Marché principal en Allemagne ; disponible dans 32 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

04049325029507

Basic UDI-DI

4049325IVR06020002BR4

Numéro de référence/catalogue

RE51021

Entité d'attribution

GS1

Catégorie de risque

IVDR Classe B

Législation applicable

IVDR [Règlement (UE) 2017/746 relatif aux dispositifs médicaux de diagnostic in vitro]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The MuSK-Ab ELISA is intended for the qualitative and semi-quantitative measurement of autoantibodies against muscle-specific receptor tyrosine kinase (MuSK) from adult patient’s serum samples. The measurement of autoantibodies against MuSK supports the diagnosis of myasthenia gravis (MG), a long-term muscle disease leading to muscle weakness of varying severity. In diagnostics, the determination of autoantibodies against MuSK is used especially in patients who have tested negative for autoantibodies against the acetylcholine receptor (AChR, 70 % of AChR-Ab seronegative patients show autoantibodies against MuSK). The MuSK-Ab ELISA is appropriate as an aid for use in the diagnosis of Myasthenia Gravis. The comprehensive detection of antibodies is necessary for the diagnosis and treatment of MG, therefore, the determination of MuSK antibodies and the determination of autoantibodies against Acetylcholine Receptor (AChR) is usually performed simultaneously. For definition of the myasthenic subgroup further diagnostic investigation is necessary. Subgroup will not be clearly defined using the anti- MuSK antibody ELISA. The MuSK-Ab ELISA is a solid phase enzyme-linked immunosorbent assay (ELISA), based on the principle of competitive binding and measured on an absorbance reader. The assay is semi-automated requiring general purpose laboratory instruments and consumables such as absorbance microplate reader/washer, vortexer and pipettes to execute the test. The assay is adaptable by laboratory personnel to automate on open ELISA based liquid handler platforms; however, the programming of the steps and timing required by the manual kit assay test instructions must be strictly adhered to and verified by the laboratory. Test results are calculated from a standard curve and compared to defined cut-off. The test kit is intended for professional laboratory use by trained personnel. The test kit is not for home or layperson use.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• W0102109099AUTO-IMMUNE DISEASE TESTS - OTHER

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