ZYMUTEST™ HIA IgG
$979.00
Enzyme Immuno-assay designed for measuring heparin-dependent antibodies of the IgG isotype, in human plasma. In US: 510(k) Clearned for In Vitro Diagnostic Use for Plasma only.
SKU: ARK040A
Manufacturer: Hyphen BioMed
Categories: Heparin Induced Thrombocytopenia (HIT), Test Kits
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.
Enzyme Immuno-assay designed for measuring heparin-dependent antibodies of the IgG isotype, in human plasma. In US: 510(k) Clearned for In Vitro Diagnostic Use for Plasma only.
Product Documents & Features
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 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.
- 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%
- Micro ELISA Plate (12 strips of 8 wells)
- 2x HIA Sample Diluent.
- 3x HIA IgG Positive Control.
- 3x Negative Control.
- 3x Platelet Lysate.
- 3x Anti-IgG (Fcγ)-HRP IC.
- 1x Conjugate Diluent.
- 1x Wash Solution.
- 1x TMB.
- 1 x 0.45M Sulfuric Acid.
- Video of Product Components(Video can be viewed with Flash Plugin)
MSDS
(1)
COA
(2)
Technical Data
(1)
IFU
(1)
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