ATK Vit D

Primary DI

06260001187139

Basic UDI-DI Code

62600011ATK.VITDAB

Reference

ATK.E071

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

Arghavan Teb Kavian

25-hydroxy (25-0H) Vitamin D ELISA is intended for the high-quality enzymatic assay for the quantitative determination of 25-hydroxyvitamin D (D2 and D3) in human serum and plasma.The Arghavan Teb Kavian’s Total 25-OH Vitamin D ELISA kit is a competitive solid phase Enzyme Linked Immunosorbent Assay performed on micro-plates. During the first 60-minute incubation step, at 37°C, total 25-OH Vitamin D (D2 and D3) present in calibrators, controls and samples is dissociated from binding serum proteins to fix on binding sites of a specific monoclonal antibody conjugated to enzyme. After incubation without washing steps, a fixed amount of 25-OH Vitamin D-labeled with biotin is added to each well of the test and incubation in 37°C is continues for another 30 minutes. During this incubation 25-OH Vitamin D-labeled with biotin competes with 25-OH Vitamin D2 and 25-OH Vitamin D3 present on the binding sites of the specific monoclonal antibody and simultaneously the immune complex attached to streptavidin molecule immobilized at the bottom of microtiter plate. After this step washing done to stop the competition reaction. The Chromogenic solution TMB/H2O2 is added and incubated for 15 minutes. The reaction is stopped with the addition of Stop solution and the micro-plate is then read at the 450nm wavelength. The amount of substrate turnover is determined color imetrically by measuring the absorbance, which is inversely proportional to the total 25-OH Vitamin D (D2 and D3) concentration. A calibration curve is plotted and the total 25-OH Vitamin D (D2 and D3) concentrations of the samples are determined by dose interpolation from the calibration curve.

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