Eu Ivdr Eu Ivd Class A On The Market

RoboBlot

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

Basic Information

Primary DI
05060969430008
Basic UDI-DI Code
506096943RB01AQ
Reference
RB01
Device Types
None provided
Regulation
Eu Ivdr
Classification
Eu Ivd Class A
Status
On The Market
Manufacturer
Bee Robotics

Additional Description

The RoboBlot is a fully automated standalone Class A in vitro diagnostics instrument used for processing up to 50 sample membranes. The RoboBlot detects the samples using a barcode reader, pipettes all reagents, performs washing of the membranes and transfers a raw image to a third party software to perform a complete analysis. The RoboBlot allows for full automation and quantitative determination of strip based assays using human serum. The assays include (but not limited to) testing for: - Lyme disease - HIV - HPV - Toxoplasma The RoboBlot is suitable for processing samples of all groups of people. It is to be used by trained personnel with samples and reagents (diagnostics kit) that are appropriate for the RoboBlot. The Product is intended for professional use.

CND Nomenclature Codes

Code Description
W0201020180 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES

Available In Countries

🇦🇹 Austria 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇾 Cyprus 🇨🇿 Czechia 🇩🇪 Germany 🇩🇰 Denmark 🇪🇪 Estonia 🇬🇷 Greece 🇪🇸 Spain 🇫🇮 Finland 🇫🇷 France 🇭🇷 Croatia 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇸 Iceland 🇮🇹 Italy 🇱🇮 Liechtenstein 🇱🇹 Lithuania 🇱🇺 Luxembourg 🇱🇻 Latvia 🇲🇹 Malta 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇸🇪 Sweden 🇸🇮 Slovenia 🇸🇰 Slovakia 🇹🇷 Türkiye 🇬🇧 United Kingdom

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