Precision Microfluidics & IVD Consumables OEM

Direct manufacturer operating under an ISO 13485-aligned quality system, specializing in precision microfluidic chips, optical-grade flow cells, and POCT consumable cartridges. Operating inside Class 100K cleanrooms with advanced micro-injection molding capabilities achieving molded tolerances down to ±5–8 µm with high Cpk reliability.

1. Microfluidic Chips & Diagnostic Cartridges

Delivering sub-micron surface finishes and ultra-tight channel tolerances critical for molecular diagnostics, digital PCR (dPCR), and point-of-care testing platforms. We empower OEM/ODM partners with end-to-end solutions—from precision mold fabrication to ISO Class 8 cleanroom mass production.

Precision Optical Microfluidic Chip with 4-Channel Micro-molding
CPK-DRIVEN TOLERANCE CONTROL

Integrated Microfluidic Chips & dPCR Plates

Engineered with high-aspect-ratio microchannels and superior optical clarity, our microfluidic chips ensure highly predictable fluid kinetics and mitigate sample cross-contamination risks. Manufactured using medical-grade COC, COP, PMMA, and PC polymers optimized for low protein adsorption and excellent chemical compatibility.

  • Channel Dimensions: Width and depth precise down to 20 µm with strict dimensional repeatability
  • Bonding Technologies: Thermal diffusion bonding, ultrasonic welding, and precision laser welding
  • Cleanroom Standards: Manufactured in ISO Class 8 facilities; DNase, RNase, and endotoxin-free production workflows available
Automated Liquid Handling Precision Reagent Micro-Array Well Plate

Micro-Array & Reaction Well Plates

High-density reaction wells engineered for seamless integration with automated liquid handling and robotic pipetting workstations.

Snap-fit Assembly of Integrated Diagnostic Cassette and Reagent Chamber

Modular Snap-Fit Cassette Assembly

Complex multi-component architectures integrating reagent storage blisters, filtration membranes, and fluidic micro-valves.

2. Optical-Grade Diagnostics & Sequencing Flow Cells

Engineered specifically for next-generation gene sequencing (NGS), fluorescence imaging, and bio-optical assays requiring ultra-high visible light transmittance (>92%) and minimized autofluorescence.

Optical Grade Flow Cell Testing and Microfluidic Perfusion Verification
MINIMIZED AUTOFLUORESCENCE

Next-Gen Sequencing (NGS) Flow Cells

Utilizing specialized cyclic olefin copolymers (COC/COP), our flow cells undergo optical-grade mirror EDM mold processing to achieve pristine surface finishes (Ra < 10 nm). This significantly mitigates optical noise interference during high-resolution laser excitation and confocal scanning operations.

  • Optical Clarity: >92% visible spectrum light transmittance, with UV-transmissible polymer options available
  • Surface Modification: Advanced plasma treatment and hydrophilic/hydrophobic surface functionalization
  • Sealing Integrity: Bubble-free micro-perfusion validated with continuous flow rate testing

3. POCT & Rapid Diagnostic Test Consumables

Scalable mass production of point-of-care biochemical testing cartridges, lateral flow cassettes, and reagent packaging solutions engineered for consistent fluidic migration and leak-proof sealing.

Integrated POCT Rapid Test Cassette with Sealed Fluidic Reservoir
HIGH-CAVITATION TOOLING OUTPUT

POCT Biochemical & Immunoassay Cartridges

Our multi-cavity precision molds (up to 64 cavities) ensure stable high-volume output with rigorous batch-to-batch consistency. The housings feature optimized ultrasonic welding energy directors and anti-overflow barriers for secure diagnostic membrane encapsulation.

  • Clinical Applications: Colloidal gold, fluorescence immunoassay, dry biochemistry, and blood gas analysis
  • Materials: Medical-Grade ABS, HIPS, Medical PP, PC (Material options compliant with USP Class VI & ISO 10993 requirements)
  • Annual Capacity: 50+ million units supported by automated assembly and continuous in-line visual inspection
Standard Lateral Flow Immunoassay Test Cassette Housing

Lateral Flow Test Cassettes

Precision-molded single/multi-channel rapid test housings engineered with tight sample-well tolerances and crystal-clear observation windows.

Diagnostic Reagent Packaging Kit, Vials, and Dropper Bottles

Reagent Vials & Packaging Kits

Leak-proof buffer dropper bottles, screw-cap microtubes, and customized reagent box packaging solutions.

Technical Capabilities & Quality Assurance

Manufacturing Parameter Specification / Standard Quality & Compliance
Cleanroom Environment ISO Class 8 (100K) Cleanroom Standards ISO 13485-Aligned Quality Management System
Micro-Molding Tolerance Tooling ±2 µm; Molded Parts ±5–8 µm (Target Cpk ≥ 1.33) Zeiss CMM & Optical Micro-Measuring Inspection
Supported Polymers COC, COP (Topas/Zeonor), PMMA, PC, Medical PP, PS Material options capable of passing USP Class VI & ISO 10993 testing
Bonding & Assembly Ultrasonic, Laser Welding, Thermal Diffusion, PSA Film 100% Air/Helium Leak Testing & Optical Defect Screening

GLOBAL SUPPLY.
LOCAL PRECISION.

We bridge the gap between world-class engineering and global medical supply chains. Whether you are in North America, Europe, or Asia, our OEM components integrate seamlessly into your production lines.

30+

Countries Served

Strict

NDA Protocols

Cpk

Driven Quality

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