RE59321

Organization name

IBL International GmbH

SRN

DE-MF-000015709

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW266

  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

04049325030664

Basic UDI-DI

4049325IVR05060001BS2

Reference / catalog number

RE59321

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 Neopterin ELISA is intended for the quantitative determination of Neopterin in human serum, plasma (EDTA) and urine in adults. Elevated neopterin levels can be measured as physiological marker for the indication of inflammation in the body, immune system activation and response activity. Neopterin is an unspecific marker for immune activation or other disturbances of the immune system and can be applied as an aid for early diagnosis of immune reaction like viral infection or allograph rejection. The Neopterin 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. 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 Thunderbolt, DSX and BEP2000. The test kit is intended for professional laboratory use by trained personnel. The test kit is not for self-testing. The Neopterin 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.

• W0102069004NEOPTERINE

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