HemosIL D-Dimer HS 500

Primary DI

08426950485605

Basic UDI-DI Code

84269504856059H

Reference

0020500100

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

Instrumentation Laboratory Company

Latex Reagent: 3 vials x 4 mL of a suspension of polystyrene latex particles coated with the F(ab’)2 fragment of a mouse monoclonal antibody (MA-8D3) directed against D-Dimer, bovine serum albumin, buffer, stabilizers and preservative. Active ingredient: F(ab')2 fragment of monoclonal antibody anti‑D-Dimer (< 0.1% w/w). Reaction Buffer: 3 vials x 6 mL of Hepes buffer containing bovine serum albumin, stabilizers and preservative. Active ingredient: none. D-Dimer Calibrator: 2 vials 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. Active ingredient: D-Dimer from human fibrin digested with human plasmin (≤0.01% w/w).

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