Eu Ivdr Eu Ivd Class A On The Market ๐Ÿ‡ง๐Ÿ‡ช Belgium

BlueDiver Instrument 2

D-tek s.a. ยท ๐Ÿ‡ง๐Ÿ‡ช Belgium
Devices (same UDI-DI)
1
Certificates
0
Countries
18
Notified Bodies
0

Basic Information

Primary DI
05425023685044
Basic UDI-DI Code
5425023685044W7
Reference
BLUEDIVER2
Device Types
None provided
Regulation
Eu Ivdr
Classification
Eu Ivd Class A
Status
On The Market
Manufacturer
D-tek s.a.

Additional Description

Automated ImmunoAssay Instrument dedicated to the carrying out of in vitro diagnosis tests. It performs the various steps of samples pipetting, incubation, washing, drying and reading of D-tekโ€™s immunodot strips, from the deposit of the sample to the final reading of the strips. The instrument can also manage other kits with equivalent BlueDiver design (strips and cartridges) The maximum capacity of the Instrument is of 24 strips which are incubated simultaneously. The Instrument is intended only for laboratory professional use and must be used only by trained personnel.

CND Nomenclature Codes

Code Description
W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)

Available In Countries

๐Ÿ‡ฆ๐Ÿ‡น Austria ๐Ÿ‡ง๐Ÿ‡ช Belgium ๐Ÿ‡จ๐Ÿ‡ฟ Czechia ๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ฌ๐Ÿ‡ท Greece ๐Ÿ‡ช๐Ÿ‡ธ Spain ๐Ÿ‡ซ๐Ÿ‡ท France ๐Ÿ‡ญ๐Ÿ‡ท Croatia ๐Ÿ‡ญ๐Ÿ‡บ Hungary ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ฑ๐Ÿ‡บ Luxembourg ๐Ÿ‡ฒ๐Ÿ‡น Malta ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands ๐Ÿ‡ต๐Ÿ‡ฑ Poland ๐Ÿ‡ต๐Ÿ‡น Portugal ๐Ÿ‡ท๐Ÿ‡ด Romania ๐Ÿ‡ธ๐Ÿ‡ฎ Slovenia ๐Ÿ‡ธ๐Ÿ‡ฐ Slovakia

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