Eu Ivdr
Eu Ivd Class B
On The Market
🇨🇭 Switzerland
MosaiQ® AiPlex CTDplus Quality Controls XL
Devices (same UDI-DI)
1
Certificates
0
Countries
7
Notified Bodies
0
Basic Information
- Primary DI
- 07640327462094
- Basic UDI-DI Code
- 764032746AIPLEXCTDPLUQCP8
- Reference
- 132003
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- AliveDx Suisse SA
Additional Description
The MosaiQ® AiPlex CTDplus Quality Controls XL (CTDplus QCs XL) are intended to be used as unassayed controls with procedures for determination of autoimmune antibodies within automated systems. The products are intended for professional use within a clinical laboratory for the qualitative screening of antibodies to native dsDNA, Sm, Sm/RNP, TRIM21, SS-A 60, SS-B, U1RNP, CENP-B, Scl70, Jo1, Ribosomal P Protein, Chromatin, CCP2, RNA Polymerase III and DFS70 in human serum samples.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102152011 | CONTROLS FOR AUTOIMMUNITY |
Available In Countries
🇧🇪 Belgium
🇨🇾 Cyprus
🇮🇪 Ireland
🇱🇺 Luxembourg
🇲🇹 Malta
🇳🇱 Netherlands
🇵🇱 Poland
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