HemosIL Protein C

Primary DI

08426950438670

Basic UDI-DI Code

84269504386708S

Reference

0020300500

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

Instrumentation Laboratory Company

Diluent: 1 x 8 mL vial of a concentrated solution containing 0.9% sodium chloride with preservative. Active ingredient: none. Protein C activator: 2 x 2.5 mL vials of a lyophilized fraction from the venom of Agkistrodon contortrix (1 unit/vial), buffer, bovine serum albumin, and preservative. Active ingredient: <0.1% (w/w) Protac®. Chromogenic substrate: 2 x 2.5 mL vials of the lyophilized chromogenic substrate S-2366 pyroGlu-Pro-Arg-pNA.HCl (3.75 mg/vial), synthetic thrombin inhibitor I-2581 (0.125 mg/vial), and bulking agent. Active ingredient: <1% (w/w) S-2366 pyroGlu-Pro-Arg-pNA.HCl. Barcode labels: 3 linear barcode labels to be placed on 10 mL diluted diluent vials (not included in kit). Linear barcode contains lot number and expiration date of concentrated diluent.

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