RE54031

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

04049325030602

Basic UDI-DI

4049325IVR06080012BTP

Reference / catalog number

RE54031

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

Enzyme immunoassay for the quantitative determination of Melatonin Sulfate in human urine. Quantification of melatonin sulfate indicates physiological functions or states of the pineal gland that regulates sleep-wake cycles. Patient population includes healthy adults and adults suspected to be affected by sleep disorders. The assay should not be performed with patient samples that might be affected by interference from exogenous melatonin or samples that might be affected by drugs that interact with melatonin metabolism. The Melatonin-Sulfate Urine 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 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 only. The test kit is not for self-testing. The Melatonin-Sulfate Urine 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.

• W0102069003MELATONINE

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