RE62149

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

04049325030541

Basic UDI-DI

4049325IVR06080011BTL

Reference / catalog number

RE62149

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 17beta-Estradiol Saliva Luminescence Immunoassay is intended for the measurement of 17-beta-Estradiol in human saliva. Estradiol is the most important natural estrogen and present in both women and men. The measurement of the hormone level is useful for detection of estrogen deficiency. Estradiol has an impact on puberty, primary and secondary amenorrhea and menopause. This test is not intended for assessing placental function in complicated pregnancy. Additonal hormone assays are recommended for an interpretation of the estradiol level. The 17beta-Estradiol Saliva Luminescence Immunoassay is based on the competition principle and measured on a microtiterplate luminescence reader. The assay is semi-automated requiring general purpose laboratory instruments and consumables such as luminescence 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 by trained personnel. The test kit is not for home or lay person use. The test kit is intended for manual use.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0102050103ESTRADIOL

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