RE52281

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

04049325030268

Basic UDI-DI

4049325IVR06080005BTT

Numéro de référence/catalogue

RE52281

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 Progesterone Saliva ELISA is intended for the quantitative determination of Progesterone in human saliva in adults and for use as an aid in the diagnosis and treatment of disorders of the ovaries or placenta. The information in addition to other clinical observations and diagnostic test is useful in assessing the level of progesterone as a determination of physiological status in adults. Changes in progesterone level demonstrates abnormal hormone productions and can be indicative for disorders of the ovaries or placenta. The Progesterone Saliva ELISA is NOT appropriate for use in the diagnosis and treatment of abnormalities of pregnancy. The Progesterone 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 by the manual kit assay test instructions must be strictly adhered to and verified by the laboratory. Test results may be calculated manually 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 home or layperson use. The device is not intended for point-of-care settings.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• W0102050106PROGESTERONE

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