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Global Healthcare Medical
GHM HbA1c US Glycosylated Hemoglobin Test Kit (FIA) – Quantitative HbA1c Testing with 5-Minute Results, 4–16% Measuring Range, and Whole Blood Compatibility
GHM HbA1c US Glycosylated Hemoglobin Test Kit (FIA) – Quantitative HbA1c Testing with 5-Minute Results, 4–16% Measuring Range, and Whole Blood Compatibility
SKU: GHM HbA1c US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM HbA1c US Glycosylated Hemoglobin Test Kit (FIA) is a fluorescence immunoassay (FIA) designed for the quantitative determination of Glycosylated Hemoglobin (HbA1c) in human whole blood samples obtained from fingerstick or venous collection. The kit is intended for use with compatible POCT Analyzers, providing healthcare professionals with a reliable tool for monitoring long-term glycemic control in individuals previously diagnosed with diabetes mellitus.
The measurement of Glycosylated Hemoglobin (HbA1c) is widely recognized as a reliable parameter in monitoring glycemia, reflecting average blood glucose levels over the preceding 2–3 months. The GHM HbA1c US Test Kit delivers results in just 5 minutes, with a measuring range of 4–16%, 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 GP offices, laboratories, and hospitals. The Glycosylated Hemoglobin Test Kit has received certification under the In Vitro Diagnostic Regulation (IVDR), underscoring its compliance with high standards of quality and safety.
Key Features & Benefits
Fluorescence Immunoassay Technology – High-Sensitivity Quantitative Detection
The GHM HbA1c US Test Kit is based on fluorescence immunoassay technology, utilizing a sandwich immunoreaction method. Fluorescence-labeled detector antibodies bind to the target protein (glycosylated hemoglobin) in the blood sample. The test device contains a membrane coated with HbA1c-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 |
| HbA1c-specific monoclonal antibodies | Targeted and accurate measurement |
| Quantitative determination | Precise HbA1c percentage results |
Fast Results – 5 Minutes
The GHM HbA1c US Test Kit provides results in just 5 minutes, supporting rapid clinical decision-making and efficient patient workflow in point-of-care settings.
| Feature | Benefit |
|---|---|
| 5-minute test time | Rapid turnaround for timely clinical decisions |
| Point-of-care compatibility | Suitable for GP offices, laboratories, and hospitals |
| Efficient workflow | Enables immediate patient consultation |
Wide Measuring Range – 4–16%
The GHM HbA1c US Test Kit supports a broad measuring range of 4–16%, accommodating a wide variety of HbA1c levels for comprehensive glycemic monitoring.
| Parameter | Specification |
|---|---|
| Measuring Range | 4–16% |
| Specimen | Whole blood (from fingerstick or venous) |
| Test Time | 5 minutes |
| Operating Temperature | 18–25°C |
| Storage Temperature | 2–30°C |
Whole Blood Compatibility – Fingerstick or Venous Samples
The GHM HbA1c US Test Kit is compatible with whole blood samples obtained from either fingerstick or venous collection, providing flexibility for different clinical workflows and patient preferences.
| Feature | Benefit |
|---|---|
| Fingerstick whole blood | Convenient point-of-care sample collection |
| Venous whole blood | Standard laboratory sample compatibility |
| Flexible sample collection | Adaptable to different clinical settings |
IVDR Certified – Quality and Safety Compliance
The Glycosylated Hemoglobin Test Kit has received certification under the In Vitro Diagnostic Regulation (IVDR), demonstrating compliance with stringent European regulatory standards for in vitro diagnostic medical devices.
| Feature | Benefit |
|---|---|
| IVDR certification | Compliance with European IVD regulations |
| Quality assurance | Meets high standards of quality and safety |
| Professional-grade | Designed for healthcare professional use |
Product Specifications
| Specification | Detail |
|---|---|
| Model / SKU | GHM HbA1c US |
| Product Type | Glycosylated Hemoglobin Test Kit (FIA) |
| Catalog Number | VID16-04-011 |
| Intended Use | Quantitative determination of Glycosylated Hemoglobin (HbA1c) in human whole blood |
| Detection Principle | Fluorescence immunoassay (FIA); sandwich immunoreaction |
| Specimen | Whole blood (from fingerstick or venous) |
| Test Time | 5 minutes |
| Measuring Range | 4–16% |
| Operating Temperature | 18–25°C |
| Storage Temperature | 2–30°C |
| Application Scenario | GP office, laboratory, hospital |
| Compatible Analyzers | POCT Analyzers (VIM series) |
| Regulatory Status | IVDR certified |
| Intended User | Professional healthcare use only |
| Package Options | 25 tests/kit |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM HbA1c US |
|---|---|
| Fluorescence immunoassay technology | High-sensitivity quantitative detection |
| 5-minute test time | Rapid turnaround for timely decisions |
| Wide measuring range | 4–16% for comprehensive HbA1c monitoring |
| Flexible sample types | Fingerstick or venous whole blood |
| IVDR certified | Compliance with European IVD regulations |
| Point-of-care compatible | Suitable for GP offices, laboratories, and hospitals |
| Reliable monitoring parameter | HbA1c reflects average glycemia over 2–3 months |
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 HbA1c 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.
