DHEA ELISA
Basic Information
- Primary DI
- 04049325030596
- Basic UDI-DI Code
- 4049325IVR06080014BTV
- Reference
- RE52221
- Device Types
-
Single use
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- IBL International GmbH
Additional 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.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102050102 | DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA) |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).