HemosIL AcuStar Anti-Cardiolipin IgM

Primary DI

08426950496960

Basic UDI-DI Code

8426950496960AS

Reference

0009802008

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

Instrumentation Laboratory Company

Anti-Cardiolipin IgM Cartridge: 1 cartridge containing 1 vial of a magnetic particle suspension coated with bovine cardiolipin and 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. The reagents are in a phosphate or borate buffer containing bovine serum albumin, bovine cardiolipin, human ß2GPI, mouse monoclonal IgM, stabilizers, and preservative. aCL IgM Calibrator 1: 1 x 1 mL barcoded tube of a solution with aCL IgM in saline solution containing bovine fetal serum, stabilizers, and preservative. aCL IgM Calibrator 2: 1 x 1 mL barcoded tube of a solution with aCL IgM in saline solution containing bovine fetal serum, stabilizers, and preservative.

Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).