HemosIL AcuStar Anti-ß2 Glycoprotein-I IgG
Basic Information
- Primary DI
- 08426950496977
- Basic UDI-DI Code
- 8426950496977BB
- Reference
- 0009802012
- 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 IgG: 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 IgG antibody labeled with isoluminol, and 1 vial of sample diluent. The reagents are in a phosphate or borate buffer containing bovine serum albumin, human ß2GPI, mouse monoclonal IgG, stabilizers, and preservative. Anti-ß2 GPI IgG Calibrator 1: 1 x 1 mL barcoded tube of a solution with aß2GPI IgG in a phosphate buffer containing bovine serum albumin, stabilizers, and preservative. Anti-ß2 GPI IgG Calibrator 2: 1 x 1 mL barcoded tube of a solution with aß2GPI IgG 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
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).