Innovative product approved: Confidence Medical’s Vitamin B12 test receives national certification.
2025-12-12 14:34
On December 12, 2025, the Jiangsu Provincial Medical Products Administration issued the “Announcement on the Approval of Registration for 206 Medical Device Products.” The “Vitamin B12 Assay Kit (Fluorescent Immunochromatographic Assay),” independently developed by Jiangsu Confidence Medical Technology Co., Ltd., has officially received Medical Device Registration Certificate No. Su Xie Zhu Zhun 20252402219. This breakthrough marks China’s achievement of technological self-reliance in the niche segment of vitamin testing within the in vitro diagnostics field, and provides a valuable tool for clinically precise assessment of neuro-metabolic functions, diagnosis and treatment of anemia, and nutritional monitoring.
### Technological Breakthrough: Filling the Domestic Gap in Fluorescent Immunochromatographic Assays
Vitamin B12 (VB12), a water-soluble vitamin essential for human health, is closely associated with megaloblastic anemia, neurodegenerative diseases, and cardiovascular disorders when its levels are deficient. Traditional detection methods rely on chemiluminescence or radioimmunoassay techniques, which suffer from drawbacks such as complex procedures, long assay times, and high costs. The kit recently approved by Confidence Medical employs fluorescence immuno-chromatographic technology. By leveraging the principle of specific antigen-antibody binding mediated by fluorescent microbeads labeled with monoclonal antibodies, this kit enables rapid and quantitative detection of VB12 levels in whole blood, serum, and plasma samples.
According to the administrative licensing information disclosed by Tianyancha, the core components of this kit include:
1. Test card: Comprises a nitrocellulose membrane, a sample pad, and a PVC board. The membrane is coated with VB12 antigen and a quality control line (DNP-BSA antigen). The sample pad is pre-loaded with fluorescent microspheres labeled with mouse anti-human VB12 monoclonal antibodies.
2. Sample diluent: Contains a buffering system including potassium chloride and potassium dihydrogen phosphate to ensure sample stability.
3. Calibration curve card: Traceability of enterprise working calibrators to national standards ensures the accuracy of test results.
Clinical validation has shown that this kit achieves a detection sensitivity of 230 pg/mL, with a linear range spanning 50–2,000 pg/mL. Its results demonstrate 98.7% consistency with those obtained using imported chemiluminescence kits. Moreover, a single test takes only 15 minutes, representing a fourfold acceleration compared to traditional methods.
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