HemosIL Silica Clotting Time

Primary DI

08426950433491

Basic UDI-DI Code

84269504334917M

Reference

0020004800

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

Instrumentation Laboratory Company

SCT Screen: 3 x 5 mL vials of a liquid preparation containing colloidal silica, buffer, and preservative. Active ingredient: <0.1% (w/w) colloidal silica. SCT Confirm: 3 x 5 mL vials of a liquid preparation containing colloidal silica, synthetic phospholipids, buffer, and preservative. Active ingredient: <0.1% (w/w) colloidal silica. SCT CaCl2: 3 x 10 mL vials of calcium chloride (0.025 Mol/L) with polybrene and preservative. Active ingredient: none.

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