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

Easy Amp Real-time Fluorescence Isothermal Detection System

Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. · 🇨🇳 China
Devices (same UDI-DI)
3
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
06974849366389
Basic UDI-DI Code
697484936W02050199W7
Reference
HWTS-EQ002
Device Types
None provided
Regulation
Eu Ivdr
Classification
Eu Ivd Class A
Status
On The Market

Additional Description

This device is an in vitro diagnostic device, based on the principle of constant temperature fluorescence amplification technology, and used together with matching nucleic acid detection reagents. It can be used clinically on nucleic acid samples (DNA/RNA) derived from human bodies or analytes taken from samples to be tested. The target nucleic acid is qualitatively detected. Operators are required to have special training in thermostatic amplification experiment technology and operation of the devices and software, and have proficient operating skills and biosafety knowledge.

CND Nomenclature Codes

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

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