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

Real-time PCR Nucleic Acid Detection System

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

Basic Information

Primary DI
16974900600039
Basic UDI-DI Code
697490060SWM-02PA
Reference
SWM-02
Device Types
None provided
Regulation
Eu Ivdr
Classification
Eu Ivd Class A
Status
On The Market

Additional Description

Real-time PCR Nucleic Acid Detection System SWM-02 performs qualitative detection of nucleic acid samples (DNA/RNA) derived from human body by triple fluorescence PCR, including nucleic acid detection and gene analysis of pathogens. The product can be used under various scenarios including CDC, emergency medical treatment, specialist examination, primary care and blood screening. The instrument consists of the control system, power system, photoelectric system, temperature control system, case component, reaction chips, software modules (installed on a windows system computer, including control software, version V1.1.1).

CND Nomenclature Codes

Code Description
W02050116 NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS

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