Amplidiag Easy Extraction Kit I

Primary DI

06430041761136

Basic UDI-DI Code

643004176B0010LS

Reference

AE-EXT-016

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

No Longer On The Market

Manufacturer

Mobidiag Ltd.

The Amplidiag® Easy Extraction Kit I is a highly optimized extraction kit containing all required buffers and reagents for extraction and purification of nucleic acids from clinical specimens. The Amplidiag Easy Extraction Kit I consists of Amplidiag Easy Lysis Buffer, Amplidiag Easy Binding Buffer, Amplidiag Easy Magnetic Beads, Amplidiag Easy Wash Buffer 1, Amplidiag Easy Wash Buffer 2, Amplidiag Easy Wash Buffer 3, and Amplidiag Easy Wash Buffer 4. The Amplidiag Easy Extraction Kit I is intended to be used with the Amplidiag Easy System, which includes the Amplidiag Easy instrument, Amplidiag Easy Process Control I, Amplidiag Easy Process Control II, Amplidiag Easy Extraction Kit I, and Amplidiag PCR Manager. The Amplidiag Easy System provides an automated workflow for magnetic bead based nucleic acid extraction and purification that can be done as a stand-alone protocol or as a part of a fully integrated workflow with PCR plate set-up when used with Amplidiag Kits. Prepared PCR plates can be transferred to the qPCR instrument for detection of Amplidiag Kit specific analytes. The Amplidiag Easy System is intended to be used in clinical laboratories by trained laboratory personnel following the manufacturer’s protocols and recommendations.

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