HemosIL AcuStar VWF:RCo

Primary DI

08426950585008

Basic UDI-DI Code

842695058500896

Reference

0009802024

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

Instrumentation Laboratory Company

VWF:RCo Reagent Cartridge for 25 determinations: 1 cartridge containing: 1 vial of a magnetic particle suspension coated with a recombinant fragment of glycoprotein Ib (rGPIbα) by means of a specific mouse monoclonal antibody, 1 vial of assay buffer containing ristocetin sulphate, a glycopeptide antibiotic isolated from Nocardia lurida, 1 vial of tracer consisting of an anti-VWF mouse monoclonal antibody labeled with isoluminol, and 1 vial of sample diluent. The reagents are in a citrate or HEPES buffer containing bovine serum albumin, mouse IgG, stabilizers, and preservative. Active Ingredients: magnetic particles coated with a mouse monoclonal antibody (2D4) directed against rGPIbα from CHO cells <1% (w/w), ABEI labelled mAB a-VWF < 0.01 % (w/w), mouse IgG < 1% (w/w). VWF:RCo Calibrator 1 (Cat. No. 0009802026): 1 x 1 mL barcoded tube of a HEPES saline solution containing bovine serum albumin, mouse IgG, stabilizers, and reservatives. Active Ingredient: mouse anti-human IgG < 1 % (w/w). VWF:RCo Calibrator 2: 2 vials: 1 x 1 mL of a lyophilized human plasma containing buffer, stabilizers, preservatives, and 1 VWF:RCo 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).