RE54041

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

04049325030589

Basic UDI-DI

4049325IVR06080013BTS

Reference / catalog number

RE54041

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 direct quantitative determination of Melatonin in human saliva. Quantification of melatonin indicates physiological functions or states of the pineal gland that regulates sleep-wake cycles. This test is applied as an aid for the diagnosis of sleep disorders. Patient population includes healthy individuals and individuals 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 test kit is intended for professional laboratory use by trained personnel. The test kit is not for home or lay person use. The test kit is intended for manual use or can be adapted to different open platform ELISA processors and can be applied to open automated platforms.

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