SelectNA Plus

Primary DI

05060969430077

Basic UDI-DI Code

506096943R12XHBR01YQ

Reference

R12-XH-MM-01

Device Types

Sterilization

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

On The Market

Manufacturer

Bee Robotics

The Select NA Plus is a semi-automated standalone Class A in vitro diagnostic instrument used for pathogen enrichment and DNA extraction of up to 12 samples. The Select NA Plus uses XYZ mechanism for the liquid handling and a column assembly for processing the columns to draw reagents through the filter using dedicated vacuum pumps. The extracted DNA is automatically transferred into a PCR tube for analysis by a PCR instrument. The Select NA Plus allows for automation and quantitative determination of PCR based assays using a variety of specimens which include (but not limited to): - EDTA Blood - Bronchoalveolar lavage - Ascites fluid - Joint aspirates - CSF - Swabs - Sonicate fluids - Various tissue biopsies The assays include (but not limited to) testing for: - Septicaemia - Joint, Bone and wound infections - Periodontitis - Bacterial meningitis - Infective endocarditis The Select NA Plus is suitable for processing samples of all groups of people. It is to be used by trained personnel with samples and reagents (diagnostics kits) that are appropriate for the Select NA Plus. The product is intended for professional use.

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