Code: ARK041A
Manufacturer’s Part Number: RK041A
Product size: Kit of 32 tests
Clearance: 510(k)

Price: $500.00


Product Description

In US: 510(k) Cleared for In Vitro Diagnostic Use for Plasma only.

Enzyme Immuno-assay designed for measuring heparin-dependent antibodies of the IgG isotype, in human plasma. This assay measures only the IgG isotype, reported as the most associated with the clinical complications of heparin dependent antibodies (HIT/HITT), allowing confirmation of the diagnosis of HIT/HITT or its clinical suspicion. However, some cases associated with only IgM and/or IgA isotypes can be missed.

This kit allows individual test as it offers a packaging for 4 individual 8 well strips along with controls.

Product Characteristics

  • Total Assay Time: 2 hr 15 min
  • Cut Off: A450 > 0.30
  • Dynamic Range: A450 up to 3.0
  • Intra-Assay CV: 4 to 6%
  • Inter-Assay CV: 5 to 8%

Product Components

  • Micro ELISA Plate (4 strips of 8 wells)
  • 2x HIA Sample Diluent
  • 4x HIA IgG Positive Control
  • 4x Negative Control
  • 4x Platelet Lysate
  • 4x Anti-IgG (Fcγ)-HRP IC
  • 1x Conjugate Diluent
  • 2x Wash Solution
  • 1x TMB
  • 1 x 0.45M Sulfuric Acid
  • Video of Product Components
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Product Applications

Individual test.

Clinical suspicion of HIT during heparin therapy.

Heparin-dependent antibodies of the IgG isotype are those strongly associated with the clinical diagnosis of HIT. The ZYMUTEST™ HIA MonoStrip IgG assay offers then a better specificity for the clinical complication of HIT, but it has less sensitivity as cases associated with only IgM and/or IgA isotypes are missed.

Material Safety Data Sheet (MSDS)

Technical Data

Certificate of Analysis (COA)

Other Documents