About Laihe Biotech

Premier IVD & POCT Manufacturer in Hangzhou, China

Hangzhou Laihe Biotech Co., Ltd. is an ISO 13485-certified in-vitro diagnostic manufacturer based in China. Built on the principles of precision, efficiency, and long-term partnership, we operate with an experienced in-house R&D team alongside modern, vertically integrated cleanroom production lines.

Whether you require high-fidelity rapid test kits for Infectious Diseases and Drugs of Abuse, or a complete OEM/ODM diagnostic solution developed to your clinical requirements, Laihe supports you at every stage with reliable manufacturing, technical expertise, and strict regulatory compliance.

Authoritative Certifications

Strict Quality Control

Reliable Delivery

High Production Capacity

What does Laihe Biotech do?

From China to 60+ Countries, LYHER® delivers trusted rapid diagnostic solutions worldwide. Our core product portfolio includes Drugs of Abuse Tests, Respiratory Disease Rapid Test Kits, and Women’s Health Rapid Test Kits — empowering healthcare providers, distributors, and brands with reliable, high-quality testing solutions across global markets.

Rapid Test Kits

High-fidelity one-step diagnostic kits engineered for maximum sensitivity and specificity in clinical point-of-care environments.

Custom OEM/ODM

Develop new diagnostic assays or adapt proven platforms to match your precise clinical, regulatory, and packaging requirements.

Sustainable Development Solutions

Committed to eco-friendly IVD production, integrating energy-efficient cleanroom operations and responsible waste management across our global supply chain.

What Can You Expect from Laihe Biotech?

We know that IVD products are more than just test kits—they are critical to patient health and your brand's reputation.

That is why we take the time to fully understand your clinical requirements and regulatory goals before mass production. From day one, you will have a dedicated QA and project contact at Laihe, ensuring complete transparency.

Smart Manufacturing

We operate a modern manufacturing facility spanning 9,200 square meters, equipped with multiple fully automated production lines dedicated to fluorescence immunoassay and colloidal gold detection platforms.

Reliable Delivery

Our automated production processes not only ensure exceptional batch-to-batch consistency but also enable a production capacity reaching hundreds of millions of units.With an average daily output of one million units, we can flexibly meet high-volume orders.

End-to-End Quality Control & Global Certifications

We have established a comprehensive quality management system. Certified under ISO 13485, ISO 9001, and MDSAP, our QC laboratory conducts rigorous validation on every batch, ensuring internationally leading sensitivity and specificity.

After-sale Support

Every product is backed by our quality guarantee — and our team stays available after each shipment to resolve any concern fast.

Disease Areas We Cover

Laihe Biotech operates from a high-capacity manufacturing facility equipped with advanced automated assembly and high-precision inspection lines. We deliver reliable diagnostic solutions across diverse global healthcare sectors.

Drugs of abuse

Respiratory disease

Infectious Disease

Women's Health

Cardiac Marker

Tumor Marker

Inflammatory Marker

Veterinary

LAIHE BIOTECH's Professional Team

Exceptional diagnostics demand exceptional teams. Laihe Biotech R&D team brings over 15 years of expertise in fluorescence immunoassay and colloidal gold platforms. By rigorously controlling the entire lifecycle—from antibody screening to mass production—we guarantee industry-leading sensitivity and batch-to-batch consistency.

To transform research into reliable global supply, Laihe Biotech Supply Chain team leverages Hangzhou’s mature IVD cluster to ensure premium quality and agile lead times. Simultaneously, our expert Regulatory Affairs team navigates complex global compliance—including EU IVDR and FDA guidelines—providing critical technical dossiers for swift market entry.

Beyond the laboratory, Laihe Biotech multilingual Sales & Documentation teams expertly manage cross-border logistics and complex customs clearance. Whether navigating rigorous European standards or fast-paced Asian markets, our collective expertise powers your global success from initial inquiry to final delivery.

LaiHe Biotech Team

R&D Engineer

Regulatory Affairs Team

Sales & Documentation Teams

Supply Chain Team

Our Manufacturing Facility

At Laihe Biotech, we operate GMP-compliant cleanrooms, quality control laboratories, and automated production lines, ensuring that every one of your products undergoes rigorous quality control.

Incoming Material Quality Control (IQC)

Strictly inspect all materials (including raw materials, chemical reagents, etc.) against precise specifications before they are released to the production line.

In-Process Quality Control (IPQC)

Execute continuous monitoring and routine patrol inspections on critical points to maintain optimal quality throughout the manufacturing process.

Semi-finished Product Quality Control (PQC)

Conduct rigorous evaluations of semi-finished products and all their components at critical process stages to ensure strict compliance with quality standards before further processing.

Finished Product Quality Control (FQC)

Perform comprehensive physical and functional inspections on every fully assembled batch to ensure peak effectiveness and full compliance with all quality requirements.

NC Membrane Dispensing Platform

Micron-level reagent striping lays precise test and control lines for repeatable results across every batch.

Automated Cutting & Slitting System

High-speed conversion of master cards into uniform strips ensures lot-to-lot consistency at scale.

Robotic Cassette Assembly Line

Automated assembly seals strips into devices with minimal human contact, raising throughput and reducing error.

Cleanroom Assembly & Packaging Line

Trained operators assemble and pack finished rapid test kits along our controlled-environment production lines, combining steady output with careful, hands-on quality at every station.

Controlled-Environment Production Workshop

Our temperature-controlled workshop runs multiple lines of fully gowned operators, scaling rapid test kit output while maintaining a clean, regulated production environment.

Gowning & Hygiene Standards

Every operator works in full PPE — hairnet, mask, gloves and lab coat — protecting product integrity throughout the manual assembly and boxing of each kit.

Our Passion

At Laihe Biotech, we believe our role goes beyond manufacturing IVD products—it is about building lasting partnerships and supporting the sustainable growth of the healthcare industry. Our values are rooted in genuine respect for our customers, team members, manufacturing partners, and the environment. We are driven by a strong commitment to our partners’ success, guided by integrity, fairness, and mutual trust.

1M+

Pcs/day

PRODUCTION EQUIPMENT

100+

PROFESSIONAL EMPLOYEES

92,000m²

FACTORY SPACE IN SQM

Our Management System Certifications

Laihe Biotech operates under a set of recognized management system certifications, reflecting our commitment to structured operations, quality consistency, and continuous improvement in the medical device industry.

ISO 13485 Certificate

ISO 9001 Certificate

MDSAP Certificate

Brazil ANVISA BGMP

We Serve Global Markets

Laihe Biotech works with healthcare providers, laboratories, and distribution partners across Europe, North America, Asia, and other international markets, delivering reliable manufacturing and consistent quality worldwide. Wherever your business operates, we provide the technical expertise and production capability needed to bring high-performance rapid test kits to market with confidence.

Latest Company News & Events

The secretary of the district party committee has visited our company for guidance and exchange.

On the afternoon of March 10th, Wang Min, Secretary of the High-tech District Committee, visited Hangzhou Laihe Biotech Co., Ltd., accompanied by Shang Liping, member of the Standing Committee and Organization Minister of the District Committee, and leade

Hangzhou Laihe Biotech Co., Ltd helps to fight the epidemic

Hangzhou Laihe Biotech Co., LtdWe, Hangzhou Laihe Biotech Co., LTD. has always focused on the development and industrialization of POCT instant diagnosis, monitoring and health information technology field. Our company integrates R&D, production, sales an

Congratulations! LYHER Self-Testing Series New Arrival

On May 6th , 2022, LYHER Self-Testing Series new products have obtained CE certificates, such as COVID-19 and Influenza A/B Antigen Test Kit for self-testing , SARS-CoV-2 Antigen Rapid Test for self-testing(Saliva), which are independently researched and