Histamine ELISA

Primary DI

04049325033177

Basic UDI-DI Code

4049325IVR06030000BRB

Reference

RE59221

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

IBL International GmbH

Enzyme immunoassay for the quantitative determination of histamine in human EDTA plasma and urine. The Histamine ELISA is useful as an aid for diagnosis of allergic disorders by assessing the patient's health status using the physiological marker histamine. Of clinical interest in the histamine determination is the quantification of the histamine release from basophilic leukocytes in allergies of the "immediate type" as well as of the histamine quantity which is present in various body fluids (plasma, urine), after allergen administration. Patient population includes adults suspected to be affected by allergies. The Histamine 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. Test results may be 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 only. The test kit is not for self-testing. The Histamine ELISA is NOT intended for near-patient testing.

Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).