HemosIL Protein S Activity

Primary DI

08426950566526

Basic UDI-DI Code

84269505665269J

Reference

0020302000

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

Instrumentation Laboratory Company

Protein S reagent: 3 x 2 mL vials of a lyophilized preparation containing recombinant human tissue factor, synthetic phospholipids, activated protein C, polybrene, buffer, stabilizers, and preservatives. Active ingredient: <0.01% (w/w) activated protein C. Calcium reagent: 3 x 6 mL vials of a liquid preparation containing calcium. Active ingredient: none Protein S deficient plasma: 3 x 2 mL vials of a lyophilized human plasma which has been artificially depleted of Protein S. Active ingredient: <100% (w/w) human plasma.

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