30121046

Nom de l'organisation

IBL International GmbH

SRN

DE-MF-000015709

Statut du fabricant

Actif

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

• CW010

  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

04049325030527

Basic UDI-DI

4049325IVR06080009BU7

Numéro de référence/catalogue

30121046

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 Estriol high sensitive Saliva ELISA is intended for the quantitative measurement of Estriol in human saliva. Estriol is an estrogen typically produced during pregnancy. Estriol level found in non-pregnant women are similar to level both during pre- and post-menopause and are similar to the level in men. The estriol saliva assay is commonly applied to monitor estriol level in women who take supplements as part of a hormone replacement therapy and as an indicator of premature delivery in pregnant women. However, this assay is not intended to be used in the context of screening for congenital disorders of the fetus (such as Down Syndrome). Additonal hormone assays are recommended for an interpretation of the level of estriol. The Estriol high sensitive Saliva 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 must be verified by the laboratory. Test results are calculated from a standard curve and compared to laboratory established reference ranges from healthy adults (i.e. normal ranges). The test kit is intended for professional laboratory use by trained personnel. The test kit is not for self-testing. The Estriol high sensitive Saliva ELISA is not intended for near-patient testing.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• W0102050202ESTRIOL

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel