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Global Healthcare Medical
GHM D-Dimer US Test Kit (FIA) – Quantitative D-Dimer Testing with 10-Minute Results, 0.05–10 μg/mL Measuring Range, and Whole Blood/Plasma Compatibility
GHM D-Dimer US Test Kit (FIA) – Quantitative D-Dimer Testing with 10-Minute Results, 0.05–10 μg/mL Measuring Range, and Whole Blood/Plasma Compatibility
SKU: GHM D-Dimer US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM D-Dimer US Test Kit (FIA) is a fluorescence immunoassay (FIA) designed for the quantitative determination of D-Dimer in human whole blood or plasma samples. The kit is intended for use with compatible POCT Analyzers, providing healthcare professionals with a reliable tool for the management and monitoring of post-therapeutic evaluation of thromboembolic disease patients.
D-dimer is a soluble fibrin degradation product that serves as a valuable biomarker for the assessment of thrombotic disorders, including deep vein thrombosis (DVT), pulmonary embolism (PE), and venous thromboembolism (VTE). The GHM D-Dimer US Test Kit delivers quantitative results in just 10 minutes, with a measuring range of 0.05–10 μg/mL, supporting efficient clinical decision-making at the point of care.
The kit is intended for in vitro diagnostic use and professional use only, suitable for application scenarios including emergency departments, clinical laboratories, and point-of-care environments. The product line is manufactured under an EN ISO 13485 certified quality management system covering in vitro diagnostic test kits and analyzers used in the detection of cardiac markers, tumor markers, infection, inflammation, renal function, diabetes, hormone, drug of abuse, anemia, and vitamins based on fluorescence immunochromatography.
Key Features & Benefits
Fluorescence Immunoassay Technology – High-Sensitivity Quantitative Detection
The GHM D-Dimer US Test Kit is based on fluorescence immunoassay technology, utilizing a double-antibody sandwich method. Fluorescence-labeled detector antibodies bind to the target protein (D-Dimer) in the sample. The test device contains a membrane coated with D-Dimer-specific monoclonal antibodies, enabling reliable and consistent quantitative detection.
| Feature | Benefit |
|---|---|
| Fluorescence immunoassay (FIA) | High-sensitivity quantitative detection |
| Double-antibody sandwich method | Reliable and consistent signal generation |
| D-Dimer-specific monoclonal antibodies | Targeted and accurate measurement |
| Quantitative determination | Precise D-Dimer concentration results |
Fast Results – 10 Minutes
The GHM D-Dimer US Test Kit provides quantitative results in just 10 minutes, supporting rapid clinical decision-making and efficient patient workflow in emergency and point-of-care settings.
| Feature | Benefit |
|---|---|
| 10-minute test time | Rapid turnaround for timely clinical decisions |
| Point-of-care compatibility | Suitable for emergency departments and clinical laboratories |
| Efficient workflow | Enables immediate patient assessment |
Wide Measuring Range – 0.05–10 μg/mL
The GHM D-Dimer US Test Kit supports a broad measuring range of 0.05–10 μg/mL, accommodating a wide variety of D-Dimer concentrations for comprehensive thrombotic disorder assessment.
| Parameter | Specification |
|---|---|
| Measuring Range | 0.05–10 μg/mL |
| Specimen | Whole blood (fingerstick or venous) or plasma |
| Test Time | 10 minutes |
| Operating Temperature | 18–25°C |
| Storage Temperature | 2–30°C |
Flexible Sample Compatibility – Whole Blood and Plasma
The GHM D-Dimer US Test Kit is compatible with whole blood samples obtained from fingerstick or venous collection, as well as plasma samples, providing flexibility for different clinical workflows and patient sample collection preferences.
| Feature | Benefit |
|---|---|
| Fingerstick whole blood | Convenient point-of-care sample collection |
| Venous whole blood | Standard laboratory sample compatibility |
| Plasma samples | Alternative sample type for flexible workflows |
| Flexible sample collection | Adaptable to different clinical settings |
ISO 13485 Certified – Quality and Safety Compliance
The product line is manufactured under an EN ISO 13485 certified quality management system, demonstrating compliance with stringent international standards for the design, development, manufacture, and distribution of in vitro diagnostic test kits and analyzers.
| Feature | Benefit |
|---|---|
| EN ISO 13485 certification | Quality management system compliance |
| Broad IVD scope | Certified for IVD test kits detecting cardiac markers, infection, inflammation, and more |
| Quality assurance | Meets high standards of quality and safety |
| Professional-grade | Designed for healthcare professional use |
Product Specifications
| Specification | Detail |
|---|---|
| Model / SKU | GHM D-Dimer US |
| Product Type | D-Dimer Test Kit (FIA) |
| Catalog Number | VID11-03-011 |
| Intended Use | Quantitative determination of D-Dimer in human whole blood or plasma |
| Detection Principle | Fluorescence immunoassay (FIA); double-antibody sandwich method |
| Specimen | Whole blood (fingerstick or venous) / Plasma |
| Test Time | 10 minutes |
| Measuring Range | 0.05–10 μg/mL |
| Operating Temperature | 18–25°C |
| Storage Temperature | 2–30°C |
| Application Scenario | Emergency department, clinical laboratory, point-of-care |
| Compatible Analyzers | POCT Analyzers (VIM series) |
| Regulatory Status | Manufactured under EN ISO 13485 certified quality management system |
| Intended User | Professional healthcare use only |
| Package Options | 25 tests/kit |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM D-Dimer US |
|---|---|
| Fluorescence immunoassay technology | High-sensitivity quantitative detection |
| 10-minute test time | Rapid turnaround for timely decisions |
| Wide measuring range | 0.05–10 μg/mL for comprehensive D-Dimer monitoring |
| Flexible sample types | Whole blood (fingerstick or venous) and plasma compatibility |
| ISO 13485 certified | Quality management system compliance |
| Point-of-care compatible | Suitable for emergency departments and clinical laboratories |
| Reliable biomarker | D-Dimer supports management and monitoring of thromboembolic disease patients |
About Global Healthcare Medical
Global Healthcare Medical is dedicated to connecting healthcare providers, retailers, and distributors with high-quality medical devices designed for reliable performance. The GHM D-Dimer US is part of our professional diagnostic line, developed to support accurate, efficient, and connected point-of-care testing in clinical environments.
Our focus is on dependable performance, clear documentation, and responsive support for professional healthcare settings.
