Real-Time PCR System

Primary DI

06972168355015

Basic UDI-DI Code

6972168353201AA

Reference

EGN9101002

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

On The Market

Manufacturer

Maccura Medical Instrument Co., Ltd.

The product is based on the principle of real-time fluorescence PCR detection and is used in conjunction with the accompanying detection reagents for qualitative and quantitative detection and melting curve detection of target nucleic acids (DNA/RNA) derived from human reproductive tract secretions, respiratory swabs, serum/plasma, whole blood, pathological tissues, urine samples and other human samples in clinical settings, including pathogenic and human genetic items. The product automates the analysis and processing of results; through the detection of target nucleic acids and other considerations relevant to the scope of application such as derivative target nucleic acids, for the diagnosis, treatment, prevention and cure process of diseases caused by that target nucleic acid. The product should be operated or used by trained professionals with knowledge of medical testing, who should not contact with patients during use. The product is an in vitro diagnostic instrument and has no special requirements for the target patient population.

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