Eu Ivdr Eu Ivd Class A On The Market 🇩🇰 Denmark

BaseTyper

PentaBase A/S · 🇩🇰 Denmark
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
05713915000540
Basic UDI-DI Code
5713915BT003PK
Reference
758
Device Types
None provided
Regulation
Eu Ivdr
Classification
Eu Ivd Class A
Status
On The Market
Manufacturer
PentaBase A/S

Additional Description

The BaseTyper™ 96.6 Flexible Real-Time PCR System is intended for performing rapid, and accurate Polymerase Chain Reactions (PCR), Reverse Transcriptase PCR (RT-PCR), quantitative PCR (qPCR), fluorescence-based melt, High-Resolution Melt (HRM), and Fluorescence Resonance Energy Transfer (FRET) based analyses. The BaseTyper™ 96.6 Flexible Real-Time PCR System obtains real-time measurements of signals from up to 96 samples in each run. Sample material is normally genetic material like RNA and DNA. The BaseTyper™ 96.6 Flexible Real-Time PCR System is intended 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 five different fluorescent channels and one FRET channel. The fluorescent signals can for example originate from DNA-binding fluorescent dyes or labelled probes.

CND Nomenclature Codes

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

Similar Devices

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

View all