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Global Healthcare Medical
GHM CK-MB US Test Kit (FIA) – Quantitative Creatine Kinase-MB Testing with 15-Minute Results, 0.3–100 ng/mL Measuring Range, and Whole Blood/Serum/Plasma Compatibility
GHM CK-MB US Test Kit (FIA) – Quantitative Creatine Kinase-MB Testing with 15-Minute Results, 0.3–100 ng/mL Measuring Range, and Whole Blood/Serum/Plasma Compatibility
SKU: GHM CK-MB US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM CK-MB US Test Kit (FIA) is a fluorescence immunoassay (FIA) designed for the quantitative determination of Creatine Kinase-MB (CK-MB) in human whole blood, serum, or plasma samples. The kit is intended for use with compatible POCT Analyzers, providing healthcare professionals with a reliable tool for the assessment of cardiac markers.
Creatine Kinase-MB (CK-MB) is an isoenzyme of creatine kinase predominantly found in cardiac muscle tissue. Measurement of CK-MB in blood serves as a valuable biochemical marker for evaluating myocardial injury and supporting the clinical assessment of patients with suspected acute coronary syndrome. The GHM CK-MB US Test Kit delivers quantitative results in just 15 minutes, with a measuring range of 0.3–100 ng/mL, supporting efficient clinical decision-making in point-of-care settings.
The kit is intended for in vitro diagnostic use and professional use only, suitable for application scenarios including emergency departments, intensive care units, 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 based on fluorescence immunochromatography.
Key Features & Benefits
Fluorescence Immunoassay Technology – High-Sensitivity Quantitative Detection
The GHM CK-MB US Test Kit is based on fluorescence immunoassay technology, utilizing a sandwich immunoreaction method. Fluorescence-labeled detector antibodies bind to the target protein (CK-MB) in the sample. The test device contains a membrane coated with CK-MB-specific monoclonal antibodies, enabling reliable and consistent quantitative detection.
| Feature | Benefit |
|---|---|
| Fluorescence immunoassay (FIA) | High-sensitivity quantitative detection |
| Sandwich immunoreaction method | Reliable and consistent signal generation |
| CK-MB-specific monoclonal antibodies | Targeted and accurate measurement |
| Quantitative determination | Precise CK-MB concentration results |
Fast Results – 15 Minutes
The GHM CK-MB US Test Kit provides quantitative results in just 15 minutes, supporting rapid clinical decision-making and efficient patient workflow in emergency and point-of-care settings.
| Feature | Benefit |
|---|---|
| 15-minute test time | Rapid turnaround for timely clinical decisions |
| Point-of-care compatibility | Suitable for emergency departments, ICUs, and clinical laboratories |
| Efficient workflow | Enables immediate patient assessment |
Wide Measuring Range – 0.3–100 ng/mL
The GHM CK-MB US Test Kit supports a broad measuring range of 0.3–100 ng/mL, accommodating a wide variety of CK-MB concentrations for comprehensive cardiac marker assessment.
| Parameter | Specification |
|---|---|
| Measuring Range | 0.3–100 ng/mL |
| Specimen | Whole blood, serum, or plasma |
| Test Time | 15 minutes |
| Operating Temperature | 18–25°C |
| Storage Temperature | 2–30°C |
| Shelf Life | 24 months |
Flexible Sample Compatibility – Whole Blood, Serum, and Plasma
The GHM CK-MB US Test Kit is compatible with whole blood, serum, or plasma samples, providing flexibility for different clinical workflows and patient sample collection preferences.
| Feature | Benefit |
|---|---|
| Whole blood samples | Point-of-care convenience without centrifugation |
| Serum samples | 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 |
| Cardiac marker scope | Certified for IVD test kits detecting cardiac markers |
| Quality assurance | Meets high standards of quality and safety |
| Professional-grade | Designed for healthcare professional use |
Product Specifications
| Specification | Detail |
|---|---|
| Model / SKU | GHM CK-MB US |
| Product Type | Creatine Kinase-MB Test Kit (FIA) |
| Catalog Number | VID45-03-011 (combo kit reference) |
| Intended Use | Quantitative determination of Creatine Kinase-MB (CK-MB) in human whole blood, serum, or plasma |
| Detection Principle | Fluorescence immunoassay (FIA); sandwich immunoreaction |
| Specimen | Whole blood / serum / plasma |
| Test Time | 15 minutes |
| Measuring Range | 0.3–100 ng/mL |
| Operating Temperature | 18–25°C |
| Storage Temperature | 2–30°C |
| Shelf Life | 24 months |
| Application Scenario | Emergency department, ICU, 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 CK-MB US |
|---|---|
| Fluorescence immunoassay technology | High-sensitivity quantitative detection |
| 15-minute test time | Rapid turnaround for timely decisions |
| Wide measuring range | 0.3–100 ng/mL for comprehensive CK-MB monitoring |
| Flexible sample types | Whole blood, serum, or plasma compatibility |
| ISO 13485 certified | Quality management system compliance |
| Point-of-care compatible | Suitable for emergency departments, ICUs, and clinical laboratories |
| Reliable cardiac marker | CK-MB supports assessment of myocardial injury |
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 CK-MB 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.
