IVD products for qualified sourcing.
Five product families available today, an expanding pipeline on request. Each family shows reference performance, model-selection inputs, and the documents that can be requested for review.
01 · Respiratory & Syndromic Molecular Panels
Multiplex molecular panels for seasonal and outbreak readiness.CORE LINE
Compatible assay, control and consumable workflows for instrument-led infectious-disease projects. Exact targets, specimen types and local intended use must be confirmed after the proposed instrument workflow is selected.
| Reference performance | Value | Note |
|---|---|---|
| Rapid isothermal amplification option | ~30 min | Result turnaround for referenced influenza A/B assay — confirm against final IFU |
| Analytical sensitivity | 1,000 copies/mL | Referenced influenza A/B assay |
| Assay format | Single-tube multiplex | Simultaneous pathogen differentiation |
| Registration status | NMPA Class III | Flagship panels; CE / FSC availability confirmed per model on request |
Assay scope
- Influenza A/B and RSV panels
- Multi-virus respiratory panels (adenovirus, metapneumovirus, rhinovirus, coronavirus options)
- Six-pathogen respiratory bacterial panels; atypical pneumonia (M. pneumoniae, B. pertussis)
- Dried-reagent format options for reduced cold-chain burden
Typical applications
- Hospital and reference laboratory respiratory-season readiness
- Fever-clinic and infectious-disease workflow build-outs
- Public-health outbreak preparedness programmes
Documents to request
- Model-specific data sheet & IFU
- CE certificate / FSC / COA, where available
- Compatible instrument & extraction reagent list
- Storage, transport and shelf-life data
02 · Molecular Workflow Instruments
A closed loop from sample partitioning to PCR analysis.CORE LINE
Instrument selection is based on throughput, site conditions and destination-market requirements; compatible assays and consumables are then scoped to the confirmed workflow.
| Reference performance | Value | Note |
|---|---|---|
| Extraction speed | 9–11 min | 1–96 samples, magnetic-bead method, no proteinase K required |
| Magnetic-bead recovery | 98% | Referenced extraction system |
| High-throughput line | 2,160 samples / 24 h | Referenced configuration — confirm per model |
| Unattended operation | 192 tests | Per operation, referenced platform |
Instrument scope
- Real-time qPCR analysis systems (multiple throughput classes)
- Automated nucleic-acid extraction: 32 / 48 / 96 channels
- Automated sample partitioning (decap, aliquot, recap)
- Full extraction workstations & liquid handling
- Plates, tubes, tips and workflow consumables
Configuration checklist
- Channels, samples per run, throughput & run time by exact model
- Supported sample types & automation level
- Barcode handling, LIS connectivity
- Voltage, installation space, environmental limits, service plan
Documents to request
- Exact-model specification & user manual
- Installation, power & maintenance requirements
- Packing dimensions, net weight, transport requirements
- Manufacturer quality documentation
03 · Infectious Disease Assay Menu
Complete the menu on the platform you already run.
Single-target and specialty PCR assays for laboratories with an installed molecular workflow — the recurring-revenue side of an instrument-led project. Assay compatibility is confirmed against the exact platform before quotation.
| Menu area | Representative assays | Reference performance |
|---|---|---|
| Hepatitis & blood-borne | HBV DNA quantification | Detection limit 500 copies/mL (ref. assay) |
| Enteric infections | Norovirus; enterovirus pan; five-pathogen diarrheagenic E. coli panel | Multiplex single-tube formats |
| Antimicrobial resistance | Carbapenemase gene detection (CRE panel) | Direct-to-genotype workflow, NMPA Class III |
| Wider portfolio | 600+ assay portfolio behind the menu — ask for availability by target | Availability confirmed per model & market |
Why this line
- Turns one instrument sale into recurring reagent revenue
- Menu breadth helps distributors win laboratory tenders
- Compatible with referenced open and closed workflows
Documents to request
- Assay IFU & performance data sheet
- CE certificate / FSC / COA, where available
- Platform compatibility list
- Cold-chain and shelf-life documentation
04 · HbA1c & Diabetes Management
Dual-technology HbA1c platforms from a pioneer exporter.CE · FDA · ISO 13485
This product line comes from a supply partner that is among China's earliest IVD exporters — 110+ countries served, 500+ distributor channels, with CE, FDA and ISO 13485 (TÜV) certification on the line.
| Platform | Technology | Best suited for |
|---|---|---|
| Benchtop HbA1c analysers (multiple throughput classes) | HPLC | Hospital laboratories and diabetes clinics requiring reference-grade precision |
| POCT HbA1c analyser (one-step) | One-step affinity / boronate method | Ward-side, GP clinics and community screening — one-step operation usable by clinicians and nurses |
| Matching reagents & controls | — | Recurring supply programme sized to installed instrument base |
Why this line
- Among the earliest HbA1c dual-technology platforms in China
- Multiple patents on HbA1c detection
- CE, FDA and ISO 13485 (TÜV) certified product line
- Recurring reagent revenue for distributors
Configuration checklist
- Method and reportable range per exact model
- Tests per day, sample loading mode
- Reagent pack format, storage temperature, shelf life
- Calibration & QC programme (IFCC / NGSP alignment)
Documents to request
- Data sheet & intended-use statement
- CE certificate / FDA registration evidence
- FSC & COA for destination market
- Operator training requirements
05 · Immunofluorescence POCT
Quantitative immunoassay at the point of care.CE · FDA · ISO 13485
Benchtop and portable immunofluorescence quantitative analysers with a focused cardiac, heart-failure and inflammation menu — a natural companion to the molecular respiratory workflow in emergency and primary-care settings.
| Reference performance | Value | Note |
|---|---|---|
| Result turnaround | 3–15 min | Quantitative output, referenced analyser |
| Sample types | Whole blood / fingertip / serum / plasma | Referenced portable configuration |
| Menu focus | cTnI · Myo · CK-MB · NT-proBNP · PCT | Cardiac, heart failure and sepsis/inflammation markers |
Product scope
- Immunofluorescence quantitative analysers (benchtop & portable)
- Cardiac panel: cTnI / Myo / CK-MB
- NT-proBNP for heart-failure management
- PCT for sepsis & antibiotic stewardship
- Controls and recurring reagent supply
Documents to request
- Data sheet, IFU & assay menu list
- CE certificate / FDA registration evidence
- Storage conditions & shelf-life data
- Compatible analyser & consumables schedule
Pipeline · On request
Expanding menu, already in supplier qualification.
The following product families are under active supplier qualification. Contact us for availability and documentation status — qualified enquiries are matched first.
Chemiluminescence immunoassay
Compact fully-automated CLIA analysers — single-test and high-throughput formats, EU CE-IVDR certified. Menu in expansion: cardiac, inflammation, thyroid, metabolic, growth markers.
Molecular point-of-care
Sample-in, result-out cartridge PCR platforms — full process in ~25 minutes, multiplex respiratory and STI menus.
Tropical disease & HPV / STI assays
Dengue, HPV genotyping and STI menus from WHO-referenced suppliers with established Southeast Asian and African registrations.