RE52281

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

04049325030268

Basic UDI-DI

4049325IVR06080005BTT

Reference / catalog number

RE52281

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 Progesterone Saliva ELISA is intended for the quantitative determination of Progesterone in human saliva in adults and for use as an aid in the diagnosis and treatment of disorders of the ovaries or placenta. The information in addition to other clinical observations and diagnostic test is useful in assessing the level of progesterone as a determination of physiological status in adults. Changes in progesterone level demonstrates abnormal hormone productions and can be indicative for disorders of the ovaries or placenta. The Progesterone Saliva ELISA is NOT appropriate for use in the diagnosis and treatment of abnormalities of pregnancy. The Progesterone Saliva 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; 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 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 by trained personnel. The test kit is not for home or layperson use. The device 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.

• W0102050106PROGESTERONE

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