ZYMUTEST™ HIA IgGAM
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ZYMUTEST™ HIA IgGAM

Code: ARK040D
Manufacturer’s Part Number: RK040D
Product size: Kit of 96 tests
Clearance: 510(k)
Price: $910.00
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Product Description

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

Enzyme immuno-assay designed for measuring globally all heparin-dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma. This assay is proposed as screening, as an early identification of heparin treated patients presenting a risk to develop HIT or HITT. This assay measures the whole of antibodies. It offers the highest sensitivity as all isotypes are detected. It is the preferred assay when an early detection of heparin dependent antibodies is required for assessing the development risk of HIT/HITT.

Product Characteristics

  • Total Assay Time: 2 hr 15 min
  • Cut Off: A450 ≥ 0.50
  • Dynamic Range: A450 up to 3.0
  • Intra-Assay CV: 4 to 6%
  • Inter-Assay CV: 5 to 8%

Product Components

  • Micro ELISA Plate (12 strips of 8 wells)
  • 2x HIA Sample Diluent.
  • 3x HIA IgGAM Positive Control.
  • 3x Negative Control.
  • 3x Platelet Lysate.
  • 3x Anti-IgG (Fcγ)-IgM (µ)-IgA(α)-HRP IC
  • 1x Conjugate Diluent.
  • 1x Wash Solution.
  • 1x TMB.
  • 1 x 0.45M Sulfuric Acid.
  • Video of Product Components
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Product Applications

Assessment of the risk to develop HIT/HITT, in patients treated with heparins (Unfractionated or LMWH): presence of antibodies is a risk indicator for development of HIT/HITT.

Clinical suspicion of HIT during heparin therapy.

Instructions For Use

Material Safety Data Sheet (MSDS)

Data Sheet/Technical Data

Certificate of Analysis (COA)

Other Documents