Eu Ivdr Eu Ivd Class A On The Market

SelectNA Plus

Devices (same UDI-DI)
1
Certificates
0
Countries
32
Notified Bodies
0

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Basic Information

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

Additional Description

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.

CND Nomenclature Codes

Code Description
W02060199 ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER

Available In Countries

๐Ÿ‡ฆ๐Ÿ‡น Austria ๐Ÿ‡ง๐Ÿ‡ช Belgium ๐Ÿ‡ง๐Ÿ‡ฌ Bulgaria ๐Ÿ‡จ๐Ÿ‡พ Cyprus ๐Ÿ‡จ๐Ÿ‡ฟ Czechia ๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ฉ๐Ÿ‡ฐ Denmark ๐Ÿ‡ช๐Ÿ‡ช Estonia ๐Ÿ‡ฌ๐Ÿ‡ท Greece ๐Ÿ‡ช๐Ÿ‡ธ Spain ๐Ÿ‡ซ๐Ÿ‡ฎ Finland ๐Ÿ‡ซ๐Ÿ‡ท France ๐Ÿ‡ญ๐Ÿ‡ท Croatia ๐Ÿ‡ญ๐Ÿ‡บ Hungary ๐Ÿ‡ฎ๐Ÿ‡ช Ireland ๐Ÿ‡ฎ๐Ÿ‡ธ Iceland ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ฑ๐Ÿ‡ฎ Liechtenstein ๐Ÿ‡ฑ๐Ÿ‡น Lithuania ๐Ÿ‡ฑ๐Ÿ‡บ Luxembourg ๐Ÿ‡ฑ๐Ÿ‡ป Latvia ๐Ÿ‡ฒ๐Ÿ‡น Malta ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands ๐Ÿ‡ณ๐Ÿ‡ด Norway ๐Ÿ‡ต๐Ÿ‡ฑ Poland ๐Ÿ‡ต๐Ÿ‡น Portugal ๐Ÿ‡ท๐Ÿ‡ด Romania ๐Ÿ‡ธ๐Ÿ‡ช Sweden ๐Ÿ‡ธ๐Ÿ‡ฎ Slovenia ๐Ÿ‡ธ๐Ÿ‡ฐ Slovakia ๐Ÿ‡น๐Ÿ‡ท Tรผrkiye ๐Ÿ‡ฌ๐Ÿ‡ง United Kingdom

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