Eu Ivdr Eu Ivd Class A Not Intended For Eu Market 🇨🇳 China

STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)

Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
06974222260464
Basic UDI-DI Code
697422226005GL
Reference
00501
Device Types
None provided
Regulation
Eu Ivdr
Classification
Eu Ivd Class A
Status
Not Intended For Eu Market

Additional Description

It is mainly used for staining of spermatozoan nucleoproteins in adult males. During the maturation of sperm, the histotype conversion of basic proteins bound to the DNA of the sperm nucleus will occur. Histones rich in lysine residues will be gradually replaced by protamine rich in arginine and cystine residues. Under acidic conditions, aniline blue will bind to lysine residues to produce a blue or violet-blue compound, thus indicating the presence of proteins rich in lysine residues, while sperm with mature nucleoproteins will be stained to red..

CND Nomenclature Codes

Code Description
W01030708 STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)

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