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Molecular Diagnostics Portfolio

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Respiratory Tract Infection Detection

Antimicrobial Resistance (AMR) Detection

Gastrointestinal Infection Detection

Blood-borne Infection Detection

Emerging Infectious Disease Detection

Molecular Diagnostic Instruments

CE｜NMPA Registration No. 20213400567

Six Respiratory Viruses Nucleic Acid Detection Kit(Fluorescent PCR Method)

CE｜ANVISA｜NMPA Registration No. 20213400828

Influenza A / Influenza B Virus Nucleic Acid Detection Kit(Fluorescent PCR Method)

NMPA Registration No. 20243400350

Bordetella Pertussis Nucleic Acid Detection Kit(Fluorescent PCR Method)

NMPA Registration No. 20243401093

Mycoplasma pneumoniae Nucleic Acid Detection Kit (Fluorescent PCR Method)

CE｜ANVISA｜NMPA Registration No. 20203400065

2019-nCoV Nucleic Acid Detection Kit (Fluorescent PCR Method)

NMPA Registration No. 20253401057

Respiratory Bacterial Pathogen Multiplex Nucleic Acid Detection Kit (Fluorescent PCR Method)

NMPA Registration No. 20243401946

Methicillin-Resistant Staphylococcus aureus Resistance Gene Detection Kit (Fluorescent PCR Method)

NMPA Registration No. 20253401578

Carbapenem-Resistance Gene Detection Kit(Fluorescent PCR Method)

CE｜NMPA Registration No. 20213400566

Norovirus Nucleic Acid Detection Kit (Fluorescent PCR Method)

CE｜NMPA Registration No. 20223400772

Universal Enterovirus Nucleic Acid Detection Kit (Fluorescent PCR Method)

NMPA Registration No. 20253402449

Hepatitis B Virus Nucleic Acid Detection Kit (Fluorescence PCR Method)

CE0123｜NMPA Registration No. 20243402478

Monkeypox Virus Nucleic Acid Detection Kit (Fluorescent PCR Method)

NMPA Registration No. 20213400714

2019-nCoV Nucleic Acid Detection Reagent (Isothermal CRISPR Method)

NMPA Registration No. 20253221199

BG-Univer-9600 Fully Automated Nucleic Acid Detection and Analysis System

CE｜NMPA Registration No. 20213220715

BG-Nova-X8 Isothermal Nucleic Acid Amplification Analyzer

NMPA Registration No. 20253222696

BG-Nova-P6 Fully Automated Nucleic Acid Analyzer

BG-X1 Handheld Rapid Nucleic Acid Testing Device

CE｜Shanghai Fengxian Medical Device Filing No. 20200062

BG-Star-96 Fully Automated Nucleic Acid Extraction & PCR System Preparation Workstation

Shanghai Fengxian Medical Device Filing No. 20200062

BG-Abot-96 Fully Automated Nucleic Acid Extractor

CE｜Shanghai Fengxian Medical Device Filing No. 20200062

BG-Flex-32/48 Fully Automated Nucleic Acid Extractor

Shanghai Fengxian Medical Device Filing No. 20220170

BG-Nege-96 Fully Automated Nucleic Acid Extractor

CE

Flix disc CH-0104 Fully Automated Nucleic Acid Analyzer

Respiratory Tract Colloidal Gold Immunochromatographic Assays

Blood-Based Biomarker Testing for Alzheimer's Disease (AD)

Infectious Disease Immunoassays

Cardiac Biomarker Detection

Coagulation and Hemostatic Disorder Detection

Fully Automated Chemiluminescence Immunoassay (CLIA) Analyzers

CE｜NMPA Registration No. 20243401411

Mycoplasma Pneumoniae IgM Antibody Detection Kit(Colloidal Gold Method)

CE｜NMPA Registration No. 20243401434

Influenza A / B Virus Antigen Detection Kit (Colloidal Gold Method)

CE｜NMPA Registration No. 20223400471

2019-nCoV Antigen Detection Kit (Colloidal Gold Method)

CE｜NMPA Registration No. 20253402190

Five Respiratory Pathogen IgM Antibody Detection Kit (Colloidal Gold Method)

Medical Device Reg. No. 20262400454 (Guangdong)

Neurofilament Light Chain Protein (NfL) Assay Kit

Medical Device Reg. No. 20262400455 (Guangdong)

Phosphorylated Tau 217 Protein (p-Tau 217) Assay Kit

Medical Device Reg. No. 20262400410 (Guangdong)

Phosphorylated Tau 181 Protein (p-Tau 181) Assay Kit

Medical Device Reg. No. 20262400346 (Guangdong)

Glial Fibrillary Acidic Protein (GFAP) Assay Kit

Medical Device Reg. No. 20262400347 (Guangdong)

β-Amyloid 1-42 (Aβ1-42) Assay Kit

Medical Device Reg. No. 20262400337 (Guangdong)

β-Amyloid 1-40 (Aβ1-40) Assay Kit

Medical Device Reg. No. 20262400151 (Guangdong)

Procalcitonin (PCT) Assay Kit (Chemiluminescence Immunoassay)

Medical Device Reg. No. 20262400016 (Guangdong)

Interleukin-6 (IL-6) Assay Kit (Chemiluminescence Immunoassay)

Medical Device Reg. No. 20262400139 (Guangdong)

Serum Amyloid A (SAA) Assay Kit (Chemiluminescence Immunoassay)

Medical Device Reg. No. 20262400142 (Guangdong)

Heparin-Binding Protein (HBP) Assay Kit (Chemiluminescence Immunoassay)

Medical Device Reg. No. 20262400153 (Guangdong)

C-Reactive Protein (CRP) Full Range Assay Kit (Chemiluminescence Immunoassay)

Medical Device Reg. No. 20262400017 (Guangdong)

Interferon-alpha (IFN-α) Detection Kit(Chemiluminescence Immunoassay)

Medical Device Reg. No. 20252401275 (Guangdong)

Tumor Necrosis Factor Alpha (TNF-α) Assay Kit(Chemiluminescence Immunoassay)

Medical Device Reg. No. 20262400060 (Guangdong)

Interferon-gamma (IFN-γ) Assay Kit(Chemiluminescence Immunoassay)

Medical Device Reg. No. 20252401373 (Guangdong)

Interleukin-1β (IL-1β) Detection Kit(Chemiluminescence Immunoassay)

Medical Device Reg. No. 20252401366 (Guangdong)

Interleukin-2 (IL-2) Detection Kit(Chemiluminescence Immunoassay)

Medical Device Reg. No. 20262400018 (Guangdong)

Interleukin-2 Receptor (IL-2R) Detection Kit(Chemiluminescence Immunoassay)

Medical Device Reg. No. 20252401375 (Guangdong)

Interleukin-4 (IL-4) Detection Kit(Chemiluminescence Immunoassay)

Medical Device Reg. No. 20252401388 (Guangdong)

Interleukin-5 (IL-5) Detection Kit(Chemiluminescence Immunoassay)

Medical Device Reg. No. 20252401377 (Guangdong)

Interleukin-8 (IL-8) Detection Kit(Chemiluminescence Immunoassay)

Medical Device Reg. No. 20252401300 (Guangdong)

Interleukin-10 (IL-10) Assay Kit (Chemiluminescence Immunoassay)

Medical Device Reg. No. 20252401364(Guangdong)

Interleukin-12p70 (IL-12p70) Assay Kit (Chemiluminescence Immunoassay)

Medical Device Reg. No. 20252401365(Guangdong)

Interleukin-17A (IL-17A) Assay Kit (Chemiluminescence Immunoassay)

Medical Device Reg. No. 20262400242 (Guangdong)

High-Sensitivity Cardiac Troponin I (hs-cTnI)Detection Kit (Chemiluminescence Immunoassay)

Medical Device Reg. No. 20262400019 (Guangdong)

Creatine Kinase Isoenzyme MB (CK-MB)Detection Kit (Chemiluminescence Immunoassay)

Medical Device Reg. No. 20262400015 (Guangdong)

Myoglobin (MYO)Detection Kit (Chemiluminescence Immunoassay)

Medical Device Reg. No. 20262400213 (Guangdong)

Soluble Growth Stimulation-Expressed Gene 2 (ST2) Detection Kit (Chemiluminescence Immunoassay)

Medical Device Reg. No. 20262400304 (Guangdong)

B-Type Natriuretic Peptide (BNP)Detection Kit (Chemiluminescence Immunoassay)

Medical Device Reg. No. 20262400345 (Guangdong)

N-Terminal Pro-B-Type Natriuretic Peptide (NT-proBNP)Detection Kit (Chemiluminescence Immunoassay)

Medical Device Reg. No. 20262400309 (Guangdong)

Lipoprotein-Associated Phospholipase A2 (Lp-PLA2)Detection Kit (Chemiluminescence Immunoassay)

Medical Device Reg. No. 20262400140 (Guangdong)

Heart-Type Fatty Acid-Binding Protein (H-FABP)Detection Kit (Chemiluminescence Immunoassay)

Medical Device Reg. No. 20262400152 (Guangdong)

High-Sensitivity C-Reactive Protein (hs-CRP)Detection Kit (Chemiluminescence Immunoassay)

Medical Device Reg. No. 20262400331 (Guangdong)

Thrombomodulin (TM)Detection Kit (Chemiluminescence Immunoassay)

Medical Device Reg. No. 20262400174 (Guangdong)

D-DimerDetection Kit (Chemiluminescence Immunoassay)

Medical Device Reg. No. 20252401658 (Guangdong)

Fibrin Degradation Products (FDP)Detection Kit (Chemiluminescence Immunoassay)

Medical Device Reg. No. 20252220113 (Shanghai)

BG-DTi 1200 Fully Automated Chemiluminescence Immunoassay Analyzer

Medical Device Reg. No. 20252220146 (Shanghai)

BG-DTi 2000 Fully Automated Chemiluminescence Immunoassay Analyzer

HbA1c Testing System

Hematology Reagents

CE｜IFCC｜NGSP｜Medical Device Reg.No. 20182220319 (Guangdong)

LD-600 Fully Automated Glycated Hemoglobin Analyzer

CE｜IFCC｜NGSP｜Medical Device Reg. No. 20212220433 (Guangdong)

LD-560 Fully Automated Glycated Hemoglobin Analyzer

CE｜IFCC｜NGSP｜Medical Device Reg. No. 20252221654 (Guangdong)

LD-100 Glycated Hemoglobin Analyzer

Blood products (for overseas sales only)

Syndromic Multi-Pathogen Surveillance Solutions

Respiratory Tract Infection Pathogens Series

Influenza Virus Assay Series

Diarrheal Disease Pathogens Series

Foodborne Pathogens Series

Hand, Foot, and Mouth Disease (HFMD) Enteroviruses Series

Encephalitis & Meningitis Pathogen Series

Vector-Borne Pathogens Series

Animal Disease Pathogen Series

Wastewater Pathogen Surveillance Series

Mobile Emergency Diagnostics Series

Syndromic Multi-Pathogen Surveillance Solutions

Respiratory Tract Infection Pathogens Series

Influenza Virus Assay Series

Diarrheal Disease Pathogens Series

Foodborne Pathogens Series

Hand, Foot, and Mouth Disease (HFMD) Enteroviruses Series

Encephalitis & Meningitis Pathogen Series

Vector-Borne Pathogen Series

Animal Disease Pathogen Series

Wastewater Pathogen Surveillance Series

Mobile Emergency Diagnostics Series

Medical Laboratory Services

Next-Generation Sequencing (NGS) & Sequencing Services

Medical Laboratory Services

Sequencing Services

Sequencing Reagents

Pseudovirus Particles, Raw Materials, and Quality Control Products

Pseudovirus Particles, Raw Materials, and Quality Control Products
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NMPA Registration No. 20253402449

Hepatitis B Virus Nucleic Acid Detection Kit (Fluorescence PCR Method)

High Sensitivity

Detection limit 5 IU/mL, minimizing low-titer virus false negatives.
Comprehensive Genotype Coverage

Coverage of all 10 HBV genotypes (A, B, C, D, E, F, G, H, I, J), reducing missed detection of positive samples
Wide Dynamic Range

Quantitative lower limit 10 IU/mL, linear range 10 IU/mL–1.0×10^9 IU/mL, aligned with clinical guidelines for chronic HBV management.
Anti-Contamination

UDG/dUTP anti-contamination system effectively degrades possible amplicon contamination in reaction tubes, reducing false positives.
Strong Resistance to Interference

Common anti-HBV drugs, such as entecavir, lamivudine, adefovir dipivoxil, telbivudine, and interferons, do not affect the test results. Common interfering substances in blood samples also do not affect the test results, effectively reducing false-negative results.