Real-Time PCR System

Primary DI

06975337671015

Basic UDI-DI Code

697533767PCR001PH

Reference

001

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

On The Market

Manufacturer

Anhui Wanyi Science and Technology Co.,Ltd.

The Real-Time PCR (GT-96) System consists of an instrument and software driving and influencing it. The system is based on the principle of real-time fluorescent PCR detection for real-time nucleic acid amplification. It is used in combination with IVD reagents (Nucleic Acid Test, NAT) for quantitative or qualitative detection of target nucleic acids (RNA/DNA) in human samples, including pathogens and human genes. The system (GT-96) is intended to be used by laboratory professionals trained in laboratory techniques and having studied the instructions for use of this system.The product (GT-96) has a maximum throughput of up to 96 samples and achieves five-color fluorescence detection. It consists of PCR thermal cycle part, real-time fluorescence detection part, electronic control part and upper computer software analysis part.

Other on-the-market devices with the same classification (Eu Ivd Class A) and regulation (EU IVDR).