Product Overview
The GOLDEN TIME Semi-quantitative hCG One-step Pregnancy Test is a professional-grade in vitro diagnostic medical device designed for the precise detection of human Chorionic Gonadotropin (hCG) in urine. Utilizing advanced colloidal gold immune chromatographic assay technology, this diagnostic tool provides a reliable, semi-quantitative assessment of pregnancy, making it an essential asset for clinical diagnostics and home-care monitoring.
Engineered for high efficiency and accuracy, the test offers a wide detection range from 25 to 10,000 mIU/ml, ensuring early and dependable results. With global certifications including CE, ISO, FSC, and NMPA, our hCG pregnancy test guarantees compliance with international medical standards, providing healthcare professionals and end-users with peace of mind and clinical confidence.
Detailed Parameters
| Product Name | Semi-quantitative hCG One-step Pregnancy Test | Brand | GOLDEN TIME |
|---|---|---|---|
| Methodology | Colloidal gold immune chromatographic assay | Specimen Type | Urine |
| Sensitivity | 25-10000mIU/ml | Accuracy Rate | ≥ 99% |
| Response Time | 1~5 minutes | Reading Window | 1-10 minutes |
| Shelf Life | 36 months | Certifications | CE, ISO, FSC, NMPA |
Key Advantages
Clinical Accuracy
Achieves a verified accuracy rate of ≥ 99%, ensuring reliable diagnostic outcomes for medical practitioners.
Rapid Results
Delivers a clear response within 1 to 5 minutes, significantly reducing patient waiting time.
Wide Sensitivity
Capable of detecting hCG levels from 25mIU/ml to 10,000mIU/ml for early detection.
OEM Customization
Fully supports buyer's logo integration for private label branding and market differentiation.
Easy Interpretation
Intuitive cassette format allows for quick and unambiguous visual reading of results.
Global Compliance
Certified by CE, ISO, FSC, and NMPA, meeting strict global regulatory requirements.
Product Gallery
Management Platforms
Supply Chain Control
Optimized inventory management for large-scale medical consumable distribution.
Quality Assurance
Strict adherence to ISO and CE standards for every production batch.
Regulatory Tracking
Continuous monitoring of NMPA and FSC compliance updates.
OEM Management
Seamless integration of client branding and custom packaging requirements.
Cold Chain Logistics
Professional storage and shipping to maintain reagent stability for 36 months.
Technical Support
Expert guidance on semi-quantitative interpretation and device handling.
Investment Return Comparison
| Metric | Standard Test Kits | GOLDEN TIME hCG Test |
|---|---|---|
| Detection Range | Fixed Threshold | Semi-Quantitative (25-10,000 mIU/ml) |
| Result Accuracy | Variable (90-95%) | High Precision (≥ 99%) |
| Turnaround Time | 10-20 Minutes | Rapid (1-5 Minutes) |
| Shelf Stability | 12-24 Months | Extended (36 Months) |
| Market Appeal | Generic Packaging | Full OEM/Private Label Support |
Frequently Asked Questions
The test is designed with a sensitivity range of 25-10,000 mIU/ml, allowing for the detection of early pregnancy with high precision.
Initial response occurs within 1 to 5 minutes, and the final reading should be conducted between 1 and 10 minutes for maximum accuracy.
Yes, it is fully certified by CE, ISO, FSC, and NMPA, ensuring it meets the regulatory requirements of most global markets.
Absolutely. We provide OEM services allowing you to integrate your own logo and brand identity on the product packaging and cassettes.
The product has a stable shelf life of 36 months when stored according to the specified conditions.
This test is specifically designed for the detection of hCG within urine specimens.