HemosIL Free Protein S

Primary DI

08426950070320

Basic UDI-DI Code

84269500703205U

Reference

0020002700

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

Instrumentation Laboratory Company

C4BP Buffer: 3 vials x 4 mL of Borax buffer containing bovine serum albumin, stabilizers, and preservative. Active ingredient: none. C4BP Latex: 3 vials x 4 mL of a lyophilized suspension of polystyrene latex particles coated with purified human C4BP containing bovine serum albumin, stabilizers, and preservative. Active ingredient: < 0.1 % (w/w) C4BP. Anti PS MAb Latex: 3 vials x 2 mL of a suspension of polystyrene latex particles coated with a monoclonal antibody directed against human protein S containing bovine serum albumin, stabilizers, and preservative. Active ingredient: < 0.1 %(w/w) monoclonal antibody anti-PS BK-21.

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