Eu Ivdr Eu Ivd Class A On The Market 🇨🇳 China

NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER

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

Basic Information

Primary DI
06937044500552
Basic UDI-DI Code
069370445acapeW9
Reference
A01010010
Device Types
None provided
Regulation
Eu Ivdr
Classification
Eu Ivd Class A
Status
On The Market

Additional Description

Measure the length of DNA or RNA fragments. The working principle is based on fluorescent labelled capillary electrophoresis fragment analysis. The method specifically includes three aspects: (a) using fluorescent dyes to label DNA or RNA fragments in the sample; (b) using DNA or RNA fragments of different lengths to migrate in an electrolyte solution at different speeds under the action of a high-voltage electric field. Phenomenon to achieve component separation; (c) adding a standard of known fragment length to the sample to generate a standard curve, and then comparing the measured fluorescently labeled DNA or RNA fragments with the standard curve to finally determine the fluorescently labeled DNA. or the length of RNA fragments. (2) Analyze the nucleic acid base sequence of DNA or RNA. The working principle is the Sanger sequencing method, that is, using the dideoxy chain end termination method, during the chain extension process, fluorescently labeled dideoxy bases are randomly blocked to generate four groups of nucleotides with different lengths ending in A, T, C and G. chain, and read the nucleic acid base sequence information by reading the fluorescent signal.

CND Nomenclature Codes

Code Description
W02050199 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER

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