HemosIL AcuStar HIT-IgG(PF4-H)

Primary DI

08426950545774

Basic UDI-DI Code

84269505457749A

Reference

0009802028

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

Instrumentation Laboratory Company

HIT-IgG(PF4-H): 1 cartridge containing 1 vial of magnetic particle suspension coated with PF4/PVS complex, 1 vial of assay buffer, 1 vial of tracer consisting of an mAb anti-human IgG antibody labeled with isoluminol, and 1 vial of sample diluent used for the regular predilution of the sample. The reagents are in a phosphate or Tris buffer containing bovine serum albumin, bovine fetal serum, PF4/PVS complex, mouse monoclonal IgG, stabilizers, and preservative. C1 HIT-IgG(PF4-H) Calibrator 1: 1 x 1 mL barcoded tube of a solution with humanized mAb anti-PF4-Heparin in Tris buffer containing bovine serum albumin, stabilizers and preservative. C2 HIT-IgG(PF4-H) Calibrator 2: 1 x 1 mL barcoded tube of a solution with humanized mAb anti-PF4-Heparin in Tris buffer containing bovine serum albumin, stabilizers, and preservative.

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