HemosIL Heparin

Primary DI

08426950042211

Basic UDI-DI Code

842695004221153

Reference

0020009400

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

Instrumentation Laboratory Company

Chromogenic substrate: 1 x 4 mL vial of the lyophilized chromogenic substrate S-2765, N-α-Z-D-Arg-Gly-Arg-pNA.2HCl (3 mg/vial), and bulking agent. Active ingredient: <1 % (w/w) S-2765, N-α-Z-D-Arg-Gly-Arg-pNA.2HCl. Factor Xa Reagent: 1 x 5 mL vial of a lyophilized preparation containing purified bovine Factor Xa (68 nkat/vial), Tris-buffer, EDTA, sodium chloride, and bovine serum albumin. Active ingredient: <1 % (w/w) bovine Factor Xa. Antithrombin: 1 x 3 mL vial of a lyophilized preparation ontaining human antithrombin (3 IU/vial), Tris-buffer, EDTA, sodium chloride, and bovine serum albumin. Active ingredient: <1 % (w/w) antithrombin. Buffer: 1 x 8 mL vial of a concentrated solution containing Tris-buffer, pH 8.4, EDTA, sodium chloride and detergent. Active ingredient: none.

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