Eu Ivdr
Eu Ivd Class B
On The Market
🇺🇸 United States
Aptiva® APS IgM Controls
Devices (same UDI-DI)
1
Certificates
0
Countries
20
Notified Bodies
0
Basic Information
- Primary DI
- 08430793040914
- Basic UDI-DI Code
- 84307930409143Y
- Reference
- 725142
- 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 Controls are intended for use with Aptiva APS IgM Reagent for quality control in 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 |
|---|---|
| W0102152011 | CONTROLS 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
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).
IDS ACE
Device
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·On the market·14 countries
IDS SHBG
Device
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·On the market·27 countries
IDS SHBG Control Set
Device
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·On the market·27 countries
1,25-Dihydroxy Vitamin D RIA
Device
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·On the market·12 countries
1,25-Dihydroxy Vitamin D RIA
Device
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·On the market·12 countries
Serum CrossLaps® (CTX-I) ELISA
Device
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·On the market·32 countries