25-OH-Vitamin D ELISA

Primary DI

04049325030152

Basic UDI-DI Code

4049325IVR06080004BTQ

Reference

RE53041

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 measurement of total 25-OH Vitamin D (25-OH Vitamin D2 and 25-OH Vitamin D3) in human serum as a physiological marker as an aid to the diagnosis of vitamin D sufficiency. Patient population includes individuals who are at risk to deviate from sufficient levels of vitamin D. The 25-OH Vitamin D 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 by the manual kit assay test instructions must be strictly adhered to and verified by the laboratory. Test results are calculated from a standard curve and compared to defined cut-off. The test kit is intended for professional laboratory use by trained personnel. The test kit is not for home or lay person use.

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