RE52651

Organization name

IBL International GmbH

SRN

DE-MF-000015709

Manufacturer status

Active

6 warnings recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.
• CW267

  EUDAMED did not publish a description for this code.
• CW011

  See IFU
• CW029

  in case of broken glas
• CW265

  See IFU and MSDS
• CW007

  See IFU

Primary placement in Germany; available across 32 countries total.

Trade name

not provided

UDI-DI code

04049325006225

Basic UDI-DI

4049325IVR06080000BTC

Reference / catalog number

RE52651

Issuing entity

GS1

Risk category

IVDR Class B

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

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.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0102050102DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification