HemosIL ISI Calibrate

Primary DI

08426950485612

Basic UDI-DI Code

84269504856129E

Reference

0020010600

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

Instrumentation Laboratory Company

ISI Level A: 1 x 1 mL vial of lyophilized human plasma with an INR range of 0.9–1.1 containing buffer. Active ingredients: human plasma (<100% w/w). ISI Level B: 1 x 1 mL vial of lyophilized human VKA plasma with an INR range of 1.6–2.4 containing buffer. Active ingredients: human VKA plasma (<100% w/w). ISI Level C: 1 x 1 mL vial of lyophilized human VKA plasma with an INR range of 2.5–3.7 containing buffer. Active ingredients: human VKA plasma (<100% w/w). ISI Level D: 1 x 1 mL vial of lyophilized human VKA plasma with an INR range of 3.8–5.0 containing buffer. Active ingredients: human VKA plasma (<100% w/w).

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