HemosIL AcuStar D-Dimer

Primary DI

08426950496946

Basic UDI-DI Code

8426950496946AY

Reference

0009802000

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

Instrumentation Laboratory Company

D-Dimer Cartridge for 100 determinations: 1 cartridge containing 1 vial of a magnetic particle suspension coated with a mouse monoclonal antibody (MA-8D3) directed against the D-Dimer domain, 1 vial of assay buffer, 1 vial of tracer consisting of an anti-XDP mouse monoclonal antibody labeled with isoluminol, and 1 vial of sample diluent used for the automatic dilution in the sample rerun. D-Dimer Calibrator 1: 1 vial x 1 mL of a lyophilized solution of D-Dimer partially purified from human fibrin digested with human plasmin containing bovine serum albumin, buffer, stabilizers and preservative. D-Dimer Calibrator 1: 1 D-Dimer Calibrator 1 barcoded plastic tube. D-Dimer Calibrator 2: 1 vial x 1 mL of a lyophilized solution of D-Dimer partially purified from human fibrin digested with human plasmin containing bovine serum albumin, buffer, stabilizers, and preservative. D-Dimer Calibrator 2: 1 D-Dimer Calibrator 2 barcoded plastic tube.

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