HemosIL D-Dimer

Primary DI

08426950060451

Basic UDI-DI Code

84269500604515Z

Reference

0020008500

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

Instrumentation Laboratory Company

Latex Reagent: 4 vials x 3 mL of a lyophilized suspension of polystyrene latex particles coated with a mouse monoclonal antibody (MA-8D3) directed against D-Dimer containing bovine serum albumin, buffer, stabilizers and preservative. Active ingredient: Monoclonal antibody anti-D-Dimer (< 0.1% w/w). Reaction Buffer: 4 vials x 9 mL of phosphate 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).