HemosIL AcuStar Multi-Ab Controls

Primary DI

08426950584926

Basic UDI-DI Code

8426950584926AE

Reference

00009800003

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

Instrumentation Laboratory Company

Low Multi-Ab Control: 3 x 2 mL barcoded tubes of a solution with human aPL IgG and IgM antibodies and an anti-PF4/H humanized monoclonal antibody in a buffer containing bovine serum albumin, stabilizers, and preservative. Active ingredient: serum aPL IgG <10% (w/w), serum aPL IgM - IgG free <10% (w/w), humanized mAb anti PF4/H <1% (w/w). High Multi-Ab Control: 3 x 2 mL barcoded tubes of a solution with human aPL IgG and IgM antibodies and an anti-PF4/H humanized monoclonal antibody in a buffer containing bovine serum albumin, stabilizers, and preservative. Active ingredient: serum aPL IgG <30% (w/w), serum aPL IgM - IgG free <80% (w/w), humanized mAb anti PF4/H <10% (w/w).

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