Diagnostic Kit for 25-HydroxyvitaminD (25-OH-VD) (Time-resolved Fluorescence Immunochromatographic Assay)

Primary DI

06974521000471

Basic UDI-DI Code

B-06974521000471

Reference

SUPF031025

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Shenzhen Superbio Technology Co.,Ltd.

This kit is suitable for quantitative determination of 25-Hydroxyvitamin D (25-OH-VD) level in human serum, plasma and whole blood. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency. Vitamin D from the diet or dermal synthesis from sunlight is biologically inactive and is a fat soluble steroid hormone involved in the active intestinal absorption of calcium and in the regulation of its homeostasis. In humans, the most important compounds in this group are vitamin D3(also known as cholecalciferol)and vitamin D2(ergocalciferol). In the liver, vitamin D3 is converted to calcidiol, 25-hydroxycholecalciferol (abbreviated 25(OH)D3. And vitamin D2 is converted in the liver to 25-hydroxyergocalciferol(25(OH)D2). It is widely known that circulating of total 25(OH)VD is the best indicator of vitamin D status. 25(OH)D3 is then converted in the kidneys into 1,25-(OH)2D3, a steroid hormone that is the active form of vitamin D. It can also be converted into 24-hydroxycalcidiol in the kidneys via 24-hydroxylation. Vitamin D has a significant role in calcium homeostasis and metabolism. Its discovery was due to effort to find the dietary substance lacking in rickets (the childhood form of osteomalacia).

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).