HemosIL AcuStar VWF:Ag

Primary DI

08426950584995

Basic UDI-DI Code

8426950584995AZ

Reference

0009802020

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

Instrumentation Laboratory Company

VWF:Ag Cartridge for 25 determinations: 1 cartridge containing: 1 vial of a magnetic particle suspension coated with a rabbit polyclonal antibody directed against VWF, 1 vial of assay buffer, 1 vial of tracer consisting of an anti-VWF rabbit polyclonal antibody labeled with isoluminol, and 1 vial of sample diluent. The reagents are in a phosphate buffer containing bovine serum albumin, rabbit polyclonal IgG, stabilizers, and preservative. Active Ingredients: magnetic particles coated with rabbit anti-VWF antibody <1% (w/w), ABEI labelled rabbit anti-VWF IgG <0.01% (w/w), rabbit IgG <1% (w/w). VWF:Ag Calibrator 1: 1 x 1 mL barcoded plastic tube of a saline solution containing preservatives. Active Ingredient: none. VWF:Ag Calibrator 2: 2 vials: 1 x 1 mL of a lyophilized human plasma containing buffer, stabilizers, and preservatives, and 1 VWF:Ag Calibrator 2 barcoded plastic tube. Active Ingredient: citrated plasma <100% (w/w).

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