BaseTyper

Primary DI

05713915000557

Basic UDI-DI Code

5713915BT004PM

Reference

759

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

On The Market

Manufacturer

PentaBase A/S

The BaseTyper™ 96.4 Flexible Real-Time PCR System is intended for performing silent, rapid, and accurate Polymerase Chain Reactions (PCR), Reverse Transcriptase PCR (RT-PCR), quantitative PCR (qPCR), and fluorescence-based melt and High-Resolution Melt (HRM) analyses. The BaseTyper™ 96.4 Flexible Real-Time PCR System obtains real-time measurements of signals from up to 96 samples in each run. The sample material is normally genetic material like RNA and DNA. The BaseTyper™ 96.4 Flexible Real-Time PCR System can be used for downstream applications, to aid in the screening, monitoring and/or diagnosis of diseases. Each well can be analysed using fluorescence in up to four different fluorescent channels. The fluorescent signals can for example originate from DNA-binding fluorescent dyes or labelled probes. Signals can be converted to qualitative, semi-quantitative or quantitative readouts. Each well can be analysed using fluorescence in up to four different fluorescent channels. The fluorescent signals can for example originate from DNA-binding fluorescent dyes or labeled probes. Signals can be converted to presence, comparative quantities, and/or physical-chemical property readouts. The instrument is intended for use by healthcare professionals or qualified laboratory personnel instructed and trained in the techniques of PCR.

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