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Basic Information
- Primary DI
- 05425023680483
- Basic UDI-DI Code
- B-05425023680483
- Reference
- LISD-24
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- D-tek s.a.
Additional Description
BlueDot LIVER IgG kits are immunodot kits allowing the detection, in human serum, of specific IgG auto-antibodies in the context of an auto-immune hepatitis or Primary Biliary Cirrhosis diagnostic. BlueDot LIVER 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 |
|---|---|
| W0102100703 | LKM1 AND RELATED PROTEINS ANTIBODIES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | BE24-00000082 | SGS United Kingdom Limited |
Available In Countries
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