STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)

Primary DI

06974222260556

Basic UDI-DI Code

697422226024GQ

Reference

02403

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

On The Market

Manufacturer

Zhuhai Cariad Medical Technology Co., Ltd.

The kit is used for staining of sperm DNA. Acridine orange is a fluorescent dye that can be specifically incorporated into the double helix structure of cell DNA. When acridine orange was mixed with double-stranded DNA, green fluorescence was produced by fluorescence excitation, while when mixed with single-stranded DNA, red fluorescence was produced by fluorescence excitation. Normal sperm DNA has a complete double helix structure, while abnormal sperm DNA has a broken single strand structure. Sperm cells treated with acridine orange were stimulated by flow cytometry and the intensity of red and green fluorescence signal was recorded. Sperm DNA fragmentation index (DFI) was obtained after calculation, which can reflect sperm DNA integrity.

The Basic UDI-DI associated with this device has 3 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).