RE52651

Nom de l'organisation

IBL International GmbH

SRN

DE-MF-000015709

Statut du fabricant

Actif

6 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.
• CW011

  See IFU
• CW029

  in case of broken glas
• CW265

  See IFU and MSDS
• CW007

  See IFU

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

Dénomination commerciale

non renseigné

Code d'UDI-DI

04049325006225

Basic UDI-DI

4049325IVR06080000BTC

Numéro de référence/catalogue

RE52651

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 DHEA Saliva ELISA is intended for the quantitative measurement of the DHEA hormone secreted by the adrenal gland using human saliva sample from adult patients. This test is intended for the measurements of DHEA levels as a physiological marker as an aid in the diagnosis and treatment of suspected dysfunction of the adrenal gland, in conjunction with other clinical parameters, such as Cortisol and other hormones. The information in addition to other clinical observations and diagnostic test is useful in assessing the level of adrenal function as a determination of physiological status in aging adults. Measurement of DHEA levels together with other hormones has been shown to be useful in the evaluation of hormone imbalance that results in various clinical conditions like hyperandrogenism (excess of androgen hormones),e.g. polycystic ovary syndrome (PCOS). Use of non-invasive sample types from saliva make the test suitable for frequent sampling and testing of DHEA levels. The DHEA Saliva ELISA is NOT appropriate for use in the diagnosis and treatment of DHEA-secreting adrenal carcinomas. The DHEA 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 lay person use.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• W0102050102DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)

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