Singclean

Primary DI

06936020140850

Basic UDI-DI Code

B-06936020140850

Reference

SP-02-2t

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Hangzhou Singclean Medical Products Co., Ltd.

[INTENDED USE] This reagent is suitable for qualitative determination of acrosomal enzyme SP10 protein in human semen in vitro. The kit can be used in assisting the diagnosis of male infertility . For professional use only. [INTRODUCTION] According to the [WHO Manual of Laboratory Testing of Human Semen] (5th edition), the main factors affecting male infertility are: semen volume, total sperm, sperm concentration, liquefaction time, semen PH value, sperm normal form rate, etc., among which sperm concentration detection is an important index to measure male infertility. In this manual, the minimum normal sperm concentration is set as 15×106 sperm /ml, and when the sperm concentration is less than 15×106 sperm /ml, fertility difficulties are considered. But male infertility needs to be combined with a number of other indicators to make a final decision. Based on a number of anatomical, genetic, and biochemical characteristics, the SP10 protein proved to be a viable analyte for sperm concentration. It is only expressed in the testis and is a differentiation marker for the last step in spermatogenesis. According to the research data, the concentration of SP10 protein has a certain linear relationship with the concentration of sperm, so this reagent can be used in assisting the diagnosis of male infertility, and at the same time provide fertility guidance for appropriate age couples.

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