Organization name

IBL International GmbH

SRN

DE-MF-000015709

Manufacturer status

Active

3 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.
• CW266

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 32 countries total.

Trade name

DHEA ELISA

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

04049325030596

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

4049325IVR06080014BTV

Reference / catalog number

RE52221

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

IVDR risk classes

IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.

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 Dehydroepiandrosterone (DHEA) in human serum. This test is intended for the measurement of DHEA levels in human serum as a physiological marker of suspected dysfunction of the adrenal gland in conjunction with additional observations. The measurement of DHEA levels serve as an aid of diagnosis for hormone imbalances that results in various clinical conditions like premature adrenarche, hyperandrogenism (excess of androgen hormones) like polycystic ovary syndrome (PCOS) or Congenital adrenal hyperplasia (CAH) and people affected by virilization or hirsutism. The test kit is intended for manual use and can be adapted to different ELISA processors like EVOlyzer. The test kit is intended for professional use. The test kit is not for home or layperson use.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0102050102DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)

• IVDR Class B medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.