STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)

Primary DI

06974222260600

Basic UDI-DI Code

697422226044GW

Reference

04401

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

Not Intended For Eu Market

Manufacturer

Zhuhai Cariad Medical Technology Co., Ltd.

This product is used for male semen leukocytes staining.SYBR dyes have membrane permeability, can bind to the nucleus and exhibit green fluorescence, and can distinguish nucleated cells (such as sperm, leukocytes, etc.) and cell debris by the fluorescent signal. All types of human leukocytes have specific antigen (CD45) expression. By detecting whether nucleated cells have the expression of CD45 antigen, leukocytes can be distinguished from other cells, thereby effectively detecting the concentration of leukocytes in semen.

The Basic UDI-DI associated with this device has 2 devices in total. Below are some other devices sharing the same Basic UDI-DI.

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