Eu Ivdr
Eu Ivd Class B
On The Market
🇺🇸 United States
Aptiva® APS IgM Calibrators
Devices (same UDI-DI)
1
Certificates
0
Countries
20
Notified Bodies
0
Basic Information
- Primary DI
- 08430793040907
- Basic UDI-DI Code
- 843079304090743
- Reference
- 725141
- Device Types
-
Single use New device
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- Inova Diagnostics. Inc.
Additional Description
Aptiva APS IgM Calibrators are intended to establish a point of reference for the working curve that is used to calculate unit values when used with the Aptiva APS IgM Reagent for semi-quantitative determination of anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (aβ2GPI) IgM autoantibodies in human serum and citrated plasma.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102152211 | STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY |
Available In Countries
🇦🇹 Austria
🇧🇪 Belgium
🇨🇾 Cyprus
🇩🇪 Germany
🇩🇰 Denmark
🇪🇸 Spain
🇫🇮 Finland
🇫🇷 France
🇭🇷 Croatia
🇮🇪 Ireland
🇮🇹 Italy
🇱🇮 Liechtenstein
🇱🇺 Luxembourg
🇱🇻 Latvia
🇲🇹 Malta
🇳🇱 Netherlands
🇵🇱 Poland
🇵🇹 Portugal
🇸🇮 Slovenia
🇬🇧 United Kingdom
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