30191569

Organization name

IBL International GmbH

SRN

DE-MF-000015709

Manufacturer status

Active

2 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.

Primary placement in Germany; available across 32 countries total.

Trade name

not provided

UDI-DI code

04049325030473

Basic UDI-DI

4049325IVR06080007BTZ

Reference / catalog number

30191569

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 Testosterone Saliva Luminescence Immunoassay is intended for the quantitative measurement of testosterone in saliva in adults. Measurement of testosterone has been shown to be useful in the evaluation of hormone imbalance that results in various clinical conditions like hypogonadism (androgen deficiency) in men and hypergonadism (excess of androgen hormones) e.g. polycystic ovaries in women. Use of non-invasive sample types from saliva make the test suitable for frequent sampling and testing of testosterone levels. The Testosterone Saliva Luminescence Immunoassay is based on the competition principle and measured on a microtiter plate luminescence reader. The assay is semi-automated requiring general purpose laboratory instruments and consumables such as luminescence microplate reader/washer, vortexer and pipettes to execute the test. 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.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0102050110TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)

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• Expiration date
• Manufacturing date
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