30201813

Organization name

IBL International GmbH

SRN

DE-MF-000015709

Manufacturer status

Active

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

• CW267

  EUDAMED did not publish a description for this code.
• CW010

  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

04049325033320

Basic UDI-DI

4049325IVR05060003BS8

Reference / catalog number

30201813

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 sInterleukin-2-Receptor ELISA is intended for the quantitative determination of human soluble IL-2 receptor (sIL-2R) in serum and plasma (EDTA, citrate, heparin). sIL-2R levels can be used as physiological marker for the indication of inflammation in the body, in-vivo immune system activation and response activity. As such the measurement of sIL-2R levels is applied as an aid in the diagnosis or monitoring of therapy of autoimmune diseases (e.g. sarcoidosis). The sinterleukin-2-Receptor ELISA is a solid phase enzyme-linked immunosorbent assay (ELISA), based on the on the sandwich principle 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. 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 manual use and can be adapted to different ELISA processors like EVOlyzer. The test kit is intended for professional laboratory use by trained personnel. The test kit is not for self-testing. The sInterleukin-2-Receptor ELISA is NOT intended for near-patient testing.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W01030607INTERLEUKINS RECEPTORS (IL-2R,IL6R ...)

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• Expiration date
• Manufacturing date
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