RE52071

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

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

Dénomination commerciale

non renseigné

Code d'UDI-DI

04049325029781

Basic UDI-DI

4049325IVR06080001BTF

Numéro de référence/catalogue

RE52071

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

Enzyme immunoassay for the in-vitro-diagnostic quantitative determination of 17-OH-Progesterone in human serum and EDTA plasma from women, men, and children. This test is intended as an aid to diagnosis and monitoring of congenital adrenal hyperplasia, in which 17-OH-Progesterone levels are found to be elevated in comparison with a corresponding population of apparently healthy individuals due to genetic 21-hydroxylase deficiency. Additionally, other clinical observations such as physical exams, quantification of other steroidal hormones (androstenedione and cortisol) and genetic testing are employed to assess the status of congenital adrenal hyperplasia. This test is intended as an aid to diagnosis and monitoring of late-onset congenital adrenal hyperplasia, in which 17-OH-Progesterone levels are found to be elevated in comparison with a corresponding population of apparently healthy individuals due to perturbations (21-hydroxylase deficiency, or androgen “backdoor” pathway) in the metabolism of 17-OH-Progesterone that leads to the accumulation of this steroid. Additionally, other clinical observations such as physical exams, quantification of other steroidal hormones (androstenedione, cortisol, and dihydrotestosterone), and genetic testing are employed to assess the status of late-onset congenital adrenal hyperplasia. In certain cases of congenital adrenal hyperplasia, 17-OH-Progesterone levels are quantified before and after stimulation with ACTH. The 17-OH-Progesterone ELISA is NOT appropriate for use in neonatal screening and for monitoring patients with hypogonadotropic hypogonadism. 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.

• W010205010717 OH PROGESTERONE

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• Date d'expiration
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