Eu Ivdd
Eu Ivd General
On The Market
๐ง๐ช Belgium
BlueDot ANA12 Screen IgG
Devices (same UDI-DI)
1
Certificates
1
Countries
18
Notified Bodies
1
Basic Information
- Primary DI
- 05425023680339
- Basic UDI-DI Code
- B-05425023680339
- Reference
- ANA12SD-24
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- D-tek s.a.
Additional Description
BlueDot ANA IgG kits are immunodot kits allowing the detection, in human serum, of anti-nuclear IgG antibodies in the context of an auto-immune disease diagnostic. BlueDot ANA IgG kits are intended to be used as confirmatory tests following indirect immunofluorescence assay (IFA), screening and reference method for auto-antibodies detection. 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 |
|---|---|
| W0102100101 | ANA SCREENING |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | BE/2400000082 | SGS United Kingdom Limited |
Available In Countries
๐ฆ๐น Austria
๐ง๐ช Belgium
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐น Italy
๐ฑ๐บ Luxembourg
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
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