ATK TSH

Primary DI

06260001187177

Basic UDI-DI Code

62600011ATK.TSH5N

Reference

ATK.R031

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

Arghavan Teb Kavian

The TSH ELISA Kit from Arghavan Teb Kavian Company is engineered for the precise quantification of Thyroid Stimulating Hormone (TSH) in serum or plasma samples.The TSH ELISA Kit from Arghavan Teb Kavian employs a sandwich-type ELISA methodology. The kit utilizes streptavidin technology to coat the solid phase. Briefly, standards, controls, or patient samples are simultaneously incubated with a conjugate reagent containing two types of TSH-specific antibodies—one biotinylated and the other conjugated to horseradish peroxidase (HRP). This allows TSH detection from two distinct epitopes, anchoring the complex to streptavidin-coated wells via biotin. Unbound components are subsequently washed away, and the addition of a substrate-chromogen solution followed by a 15-minute incubation results in the formation of a blue color. The reaction is halted with a stop solution, and the optical density is measured at 450 nm. The color intensity directly correlates with the TSH concentration in the sample.

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