Anti-Mullerian Hormone (AMH)Test Kit (Fluorescence immunochromatography method)

Trade name

Anti-Mullerian Hormone (AMH)Test Kit (Fluorescence immunochromatography method)

UDI-DI code

06976374750848

Basic UDI-DI

B-06976374750848

Reference / catalog number

20 tests / kit（DR023-2）

Issuing entity

GS1

Risk category

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

For in vitro quantitative determination of anti-Mullerian hormone (AMH) in human serum. Anti-Müllerian hormone (AMH) is a dimeric glycoprotein belonging to the transforming growth factor β (TGFβ) family. It is mainly secreted by Sertoli cells in male testes and ovarian cells in females. Its secretion level is stable and is not affected by factors such as age and weight. It is an important indicator reflecting the endocrine and related organ functions. This test can assist in evaluating the endocrine regulation homeostasis in the body and be used to assist in the diagnosis and monitoring of related endocrine diseases. Specifically, it includes: auxiliary diagnosis of pediatric sexual development disorders (DSD), monitoring of polycystic ovary syndrome (PCOS) condition, screening of endocrine system dysfunction, and can also assist in evaluating the functional status of related organs, providing reliable laboratory reference basis for clinical diagnosis and condition monitoring.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0102160999INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT & POC - OTHER

No certificate specifically references this device's Basic UDI-DI.