HemosIL AcuStar ADAMTS13 Activity

Primary DI

08426950602422

Basic UDI-DI Code

84269506024226L

Reference

0009802048

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

Instrumentation Laboratory Company

ADAMTS13 Activity Reagent Cartridge for 25 determinations: 1 cartridge containing: 1 vial of lyophilized magnetic particles coated with a recombinant GST-VWF73 peptide substrate,1 vial of Assay Buffer, and 1 vial of Tracer consisting of a monoclonal antibody labeled with isoluminol. The reagents are in a MES or HEPES buffer containing bovine serum albumin, trehalose, gelatin hydrolyzate, mouse IgG, stabilizers, and preservatives. ADAMTS13 Activity Buffer: 1 x 1.8 mL vial of a solution containing stabilizers and preservatives. Active Ingredient: none. ADAMTS13 Activity Calibrator 0: 1 x 1 mL barcoded vial of a saline solution containing preservatives. Active Ingredient: none. ADAMTS13 Activity Calibrator 1: 2 vials: 1 x 1 mL of a lyophilized human plasma and 1 ADAMTS13 Activity Calibrator 1 barcoded plastic tube. Active Ingredient: treated human plasma (lyophilized) ≤ 100% (w/w). ADAMTS13 Activity Calibrator 2: 2 vials: 1 x 1 mL of a lyophilized human plasma containing buffer, stabilizers, preservatives, and 1 ADAMTS13 Activity Calibrator 2 barcoded plastic tube. Active Ingredient: treated human plasma (lyophilized) ≤ 100% (w/w).

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