BaseTyper

Primary DI

05713915000144

Basic UDI-DI Code

5713915BT002PH

Reference

712

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

On The Market

Manufacturer

PentaBase A/S

The BaseTyper™ 16.2 Portable 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 analyses. The BaseTyper™ 16.2 Portable Real-Time PCR System obtains real-time measurements of signals from up to 16 samples in each run. Sample material is normally genetic material like RNA and DNA. The BaseTyper™ 16.2 Portable Real-Time PCR System can easily be moved close to the sample of interest and be used in as well as outside laboratories. 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. 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).