HemosIL Factor V Leiden (APC Resistance V)

Primary DI

08426950062424

Basic UDI-DI Code

84269500624246C

Reference

0020008700

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

Instrumentation Laboratory Company

APTT reagent: 2 x 4 mL vials of purified phospholipids with colloidal silica as contact activator. Active ingredient: <1% (w/w) colloidal silica. Factor V Reagent Plasma: 2 x 4 mL vials of lyophilized human plasma with a low level of factor V activity and filler. Active ingredient: <100% (w/w) human plasma. APC/Calcium chloride: 2 x 2 mL vials of human APC co-lyophilized with CaCl2. Active ingredient: <1% (w/w) activated protein C. Calcium chloride: 2 x 2 mL vials of calcium chloride in Tris buffer containing bovine serum albumin. Active ingredient: none. APC Control Plasma Level 1: 2 x 1 mL vials of lyophilized human normal plasma. Active ingredient: <100% (w/w) human plasma. APC Control Plasma Level 2: 2 x 1 mL vials of lyophilized human abnormal plasma. Active ingredient: <100% (w/w) human plasma.

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