HemosIL Chromogenic Factor IX

Primary DI

00195226000009

Basic UDI-DI Code

0195226000009PS

Reference

0020001900

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

Instrumentation Laboratory Company

Reagent A: 2 vials x 1.4 mL of a lyophilized preparation containing human factor VIII, human factor X, bovine factor V, bovine serum albumin and a fibrin polymerization inhibitor. Reagent B: 2 vials x 8 mL of a lyophilized preparation containing human factor XIa,human factor II, bovine serum albumin, calcium chloride and phospholipids. Substrate: 1 vial x 6 mL of a solution containing 2.5 mmol/L chromogenic factor Xa substrate (Z-D-Arg-Gly-Arg-pNA), a thrombin inhibitor and preservative. Buffer: 1 vial x 20 mL of a stock solution of buffer containing a heparin antagonist, bovine serum albumin and preservative. Diluted Buffer Barcode Labeled Vials: 2 x 30 mL empty vials with linear barcode labels for Diluted Buffer.

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