30121046

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

04049325030527

Basic UDI-DI

4049325IVR06080009BU7

Reference / catalog number

30121046

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 Estriol high sensitive Saliva ELISA is intended for the quantitative measurement of Estriol in human saliva. Estriol is an estrogen typically produced during pregnancy. Estriol level found in non-pregnant women are similar to level both during pre- and post-menopause and are similar to the level in men. The estriol saliva assay is commonly applied to monitor estriol level in women who take supplements as part of a hormone replacement therapy and as an indicator of premature delivery in pregnant women. However, this assay is not intended to be used in the context of screening for congenital disorders of the fetus (such as Down Syndrome). Additonal hormone assays are recommended for an interpretation of the level of estriol. The Estriol high sensitive 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 must be verified by the laboratory. Test results are 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 professional laboratory use by trained personnel. The test kit is not for self-testing. The Estriol high sensitive Saliva 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.

• W0102050202ESTRIOL

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