Eu Ivdd Eu Ivd General On The Market 🇧🇪 Belgium

BlueDot Chromatin IgG

D-tek s.a. · 🇧🇪 Belgium
Devices (same UDI-DI)
1
Certificates
0
Countries
18
Notified Bodies
0

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Basic Information

Primary DI
05425023680568
Basic UDI-DI Code
B-05425023680568
Reference
CHRD-24
Device Types
None provided
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market
Manufacturer
D-tek s.a.

Additional Description

BlueDot Chromatin IgG kits are confirmatory immunodot tests allowing the detection, in human serum, of specific anti-nuclear IgG antibodies, following an homogeneous pattern obtained by indirect immunofluorescence assay (IFA), screening and reference method for auto-antibodies detection, in the context of an auto-immune disease diagnostic. The tests are intended for a large, routine population. The kits are strictly reserved for professional use, by trained staff. The kits must be processed manually on a rotary shaker platform.

CND Nomenclature Codes

Code Description
W0102100107 HISTONES (H1, H2A, H3, H4,…HN)

Available In Countries

🇦🇹 Austria 🇧🇪 Belgium 🇨🇿 Czechia 🇩🇪 Germany 🇬🇷 Greece 🇪🇸 Spain 🇫🇷 France 🇭🇷 Croatia 🇭🇺 Hungary 🇮🇹 Italy 🇱🇺 Luxembourg 🇲🇹 Malta 🇳🇱 Netherlands 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇸🇮 Slovenia 🇸🇰 Slovakia

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