Diagnostic Kit for Anti-Müllerian Hormone (AMH) (Time-resolved Fluorescence Immunochromatographic Assay)

Primary DI

06974521000488

Basic UDI-DI Code

B-06974521000488

Reference

SUPF030025

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 Anti-Müllerian Hormone(AMH) in human serum, plasma or whole blood samples. AMH is secreted by the supportive cells of the testis in men. In male embryonic development, AMH secretion by testicular supporting cells is responsible for the decline of the mullerian canal and the normal development of the male reproductive tract. AMH continues to develop from the testicles until puberty, and then slowly decreases to a post-pubertal level. In women, AMH plays an important role in ovarian follicular development. AMH is almost undetectable at new birth in women, which reaches its highest level after puberty, then gradually declines with age and becomes undetectable after menopause. The AMH test is clinically used to assess ovarian reserve to reflect the number of preantral follicle and to predict the response to controlled ovulation.

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