DB52181

Organization name

IBL International GmbH

SRN

DE-MF-000015709

Manufacturer status

Active

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

• CW266

  EUDAMED did not publish a description for this code.
• 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

04049325030695

Basic UDI-DI

4049325IVR06080015BTY

Reference / catalog number

DB52181

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 Free Testosterone ELISA is intended for the measurement of free testosterone in serum in adults. Measurement of free testosterone is an aid in diagnosis 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. The Free Testosterone 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 like Evolyzer or DSX; 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 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. The Free Testosterone ELISA 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)

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