Eu Ivdr
Eu Ivd Class B
On The Market
🇺🇸 United States
HemosIL AcuStar Anti-ß2 Glycoprotein-I IgM
Devices (same UDI-DI)
1
Certificates
0
Countries
31
Notified Bodies
0
Basic Information
- Primary DI
- 08426950496984
- Basic UDI-DI Code
- 8426950496984B8
- Reference
- 0009802016
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- Instrumentation Laboratory Company
Additional Description
Anti-ß2 Glycoprotein-I IgM: 1 cartridge containing 1 vial of a magnetic particle suspension coated with human purified ß2GPI, 1 vial of assay buffer, 1 vial of tracer consisting of an anti-human IgM antibody labeled with isoluminol, and 1 vial of sample diluent. C1 Anti-ß2 GPI IgM Calibrator 1: 1 x 1 mL barcoded tube of a solution with aß2GPI IgM in a phosphate buffer containing bovine serum albumin, stabilizers, and preservative. C2 Anti-ß2 GPI IgM Calibrator 2: 1 x 1 mL barcoded tube of a solution with aß2GPI IgM in a phosphate buffer containing bovine serum albumin, stabilizers, and preservative.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102100503 | ANTI-B2-GLYCOPROTEIN I ANTIBODIES |
Available In Countries
🇦🇹 Austria
🇧🇪 Belgium
🇧🇬 Bulgaria
🇨🇾 Cyprus
🇨🇿 Czechia
🇩🇪 Germany
🇩🇰 Denmark
🇬🇷 Greece
🇪🇸 Spain
🇫🇮 Finland
🇫🇷 France
🇭🇷 Croatia
🇭🇺 Hungary
🇮🇪 Ireland
🇮🇸 Iceland
🇮🇹 Italy
🇱🇮 Liechtenstein
🇱🇹 Lithuania
🇱🇺 Luxembourg
🇱🇻 Latvia
🇲🇹 Malta
🇳🇱 Netherlands
🇳🇴 Norway
🇵🇱 Poland
🇵🇹 Portugal
🇷🇴 Romania
🇸🇪 Sweden
🇸🇮 Slovenia
🇸🇰 Slovakia
🇹🇷 Türkiye
🇬🇧 United Kingdom
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