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Global Healthcare Medical

GHM Insulin US Test Kit (FIA) – Quantitative Insulin Testing with 15-Minute Results, 2–300 mIU/L Measuring Range, and Serum/Plasma Compatibility

GHM Insulin US Test Kit (FIA) – Quantitative Insulin Testing with 15-Minute Results, 2–300 mIU/L Measuring Range, and Serum/Plasma Compatibility

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SKU: GHM Insulin US
Brand: Global Healthcare Medical

Product Overview

Global Healthcare Medical GHM Insulin US Test Kit (FIA) is a fluorescence immunoassay (FIA) designed for the quantitative determination of insulin in human serum or plasma samples. The kit is intended for use with compatible POCT Analyzers, providing healthcare professionals with a reliable tool for evaluating pancreatic beta-cell function and supporting the assessment of glucose metabolism disorders.

The measurement of insulin is recognized as a valuable parameter in assessing pancreatic function and glucose metabolism. The GHM Insulin US Test Kit delivers quantitative results in just 15 minutes, with a measuring range of 2–300 mIU/L, 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 laboratories, clinics, and hospitals. The Insulin 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 Insulin US Test Kit is based on fluorescence immunoassay technology, utilizing a double-antibody sandwich method. Fluorescence-labeled detector antibodies bind to the target protein (insulin) in the sample. The test device contains a membrane coated with insulin-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
Insulin-specific monoclonal antibodies Targeted and accurate measurement
Quantitative determination Precise insulin concentration results

Fast Results – 15 Minutes

The GHM Insulin US Test Kit provides quantitative results in just 15 minutes, supporting rapid clinical decision-making and efficient patient workflow in point-of-care settings.



Feature Benefit
15-minute test time Rapid turnaround for timely clinical decisions
Point-of-care compatibility Suitable for laboratories, clinics, and hospitals
Efficient workflow Enables immediate patient consultation

Wide Measuring Range – 2–300 mIU/L

The GHM Insulin US Test Kit supports a broad measuring range of 2–300 mIU/L, accommodating a wide variety of insulin levels for comprehensive metabolic monitoring.



Parameter Specification
Measuring Range 2–300 mIU/L
Specimen Serum or plasma
Test Time 15 minutes
Sample Volume 75 µL
Storage Temperature 2–30°C

Serum and Plasma Compatibility – Flexible Sample Collection

The GHM Insulin US Test Kit is compatible with serum or plasma samples, providing flexibility for different clinical workflows and patient sample collection preferences.



Feature Benefit
Serum samples Standard laboratory sample compatibility
Plasma samples Alternative sample type for flexible workflows
Flexible sample collection Adaptable to different clinical settings

IVDR Certified – Quality and Safety Compliance

The Insulin 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 Insulin US
Product Type Insulin Test Kit (FIA)
Intended Use Quantitative determination of insulin in human serum or plasma
Detection Principle Fluorescence immunoassay (FIA); double-antibody sandwich method
Specimen Serum or plasma
Sample Volume 75 µL
Test Time 15 minutes
Measuring Range 2–300 mIU/L
Storage Temperature 2–30°C
Shelf Life 18–24 months (refer to product label)
Application Scenario Laboratory, clinic, 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 Insulin US
Fluorescence immunoassay technology High-sensitivity quantitative detection
15-minute test time Rapid turnaround for timely decisions
Wide measuring range 2–300 mIU/L for comprehensive insulin monitoring
Flexible sample types Serum or plasma compatibility
IVDR certified Compliance with European IVD regulations
Point-of-care compatible Suitable for laboratories, clinics, and hospitals
Reliable monitoring parameter Insulin assessment supports evaluation of pancreatic function

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 Insulin 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.

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