Eu Ivdr
Eu Ivd Class B
On The Market
🇨🇭 Switzerland
MosaiQ® AiPlex CD Quality Controls
Devices (same UDI-DI)
1
Certificates
0
Countries
9
Notified Bodies
0
Basic Information
- Primary DI
- 07640327462063
- Basic UDI-DI Code
- 764032746AIPLEXCDQCSZ5
- Reference
- 132010
- 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 CD Quality Controls are multianalyte (IgA and IgG antibodies against tTG (tissue Transglutaminase) and DGP (Deamidated Gliadin Peptide)) quality controls derived from pooled human sera. They are unassayed qualitative controls intended to verify the performance of automated Celiac immunoassays in a professional clinical laboratory setting. This includes trending the system performance of these immunoassays.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102152011 | CONTROLS FOR AUTOIMMUNITY |
Available In Countries
🇧🇪 Belgium
🇨🇾 Cyprus
🇮🇪 Ireland
🇮🇸 Iceland
🇱🇺 Luxembourg
🇲🇹 Malta
🇳🇱 Netherlands
🇵🇱 Poland
🇬🇧 United Kingdom
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