PathoNostics Color Calibration kit

Primary DI

08719327498026

Basic UDI-DI Code

87193274980PN-507GC

Reference

PN-507

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

On The Market

Manufacturer

PathoNostics B.V.

The PathoNostics Color Calibration kit is a non-automated in vitro medical device for the qualitative measurement of fluorescent signals from oligonucleotide probes with specific spectral properties suitable to generate a Color Compensation object or dye calibration file. The PathoNostics Color Calibration kit is an Accessory medical device which possesses no critical characteristics intended for compensation of fluorescence crosstalk between detection channels in the Roche LightCycler® 480 II and for the creation of Dye calibration files for the Thermo Fisher QuantStudio™ 5 and Bio-Rad CFX™ (Opus) 96 instruments. The compensation of fluorescence crosstalk and creation of the Dye calibration files is required for correct data interpretation when using PathoNostics products on the Roche LightCycler® 480 II, Thermo Fisher QuantStudio™ 5 and Bio-Rad CFX™ (Opus) 96 instruments. Intended User: The product is intended for use by laboratory professionals only.

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