One-Stop In Vitro Diagnostics (IVD) CDMO Partner | From Lab to Market
Expert Call: (86) 23-86916205
IVDCDMO | One-Stop In Vitro Diagnostics ( IVD ) CDMO Services
One-Stop In Vitro Diagnostics (IVD) CDMO Partner
Accelerating Diagnostic Innovation from Lab to Market
From assay development and pilot production to GMP manufacturing and global regulatory support, we help diagnostic startups and biotech companies commercialize innovative IVD products faster and more efficiently.
IVDCDMO | One-Stop In Vitro Diagnostics ( IVD ) CDMO Services
Lateral Flow Assay & POCT Development Services
End-to-End IVD CDMO Solutions for Antibody & Diagnostic Assay Development
Professional support for rapid diagnostic test development, antibody screening, sensitivity optimization, stability validation, and manufacturing scale-up for POCT, ELISA, CLIA, FIA, and molecular diagnostics.
IVDCDMO | One-Stop In Vitro Diagnostics ( IVD ) CDMO Services
IVDR, FDA & Global Regulatory Support
Helping IVD Startups Achieve Faster Market Entry
Our experienced technical and regulatory team supports ISO 13485 systems, IVDR documentation, FDA 510(k) preparation, clinical validation, and diagnostic commercialization for global markets.
About IVD CDMO Platform

End-to-End IVD CDMO Solutions

IVD CDMO Laboratory
From Innovation and R&D to Rapid Market Launch—End-to-End IVD CDMO Solutions
ISO 13485 Certified manufacturer

IVD CDMO is a specialized In Vitro Diagnostics (IVD) CDMO platform dedicated to assay development, diagnostic manufacturing, immunoreagent optimization, and global regulatory support for biotech companies and diagnostic startups worldwide.

Based in Chongqing, China, our experienced scientific and technical team supports the development and commercialization of high-performance diagnostic solutions across POCT, ELISA, CLIA, FIA, lateral flow assays, and molecular diagnostics.

In Vitro Diagnostics (IVD) CDMO Services
Assay Development & GMP Manufacturing
ISO 13485 & Global Regulatory Support
IVD CDMO Time to Market: 9 Months 50%
Time to market in the industry: 18 months 100%
IVDCDMO | One-Stop In Vitro Diagnostics ( IVD ) CDMO Services
Strict Quality Practices
New Advanced Instruments
Customized Lab Solutions
Industry Standards
Time to market in the industry: 18 months 100%
IVDCDMO Standards
Time to market : 9 months 50%
In Vitro Product Development
ISO 13485 Certified Quality Management for Global IVD Markets

Quality & Compliance for Reliable Diagnostic Manufacturing

We maintain a rigorous quality management system designed to support reliable IVD antibody production, regulatory compliance, and consistent diagnostic performance for global biotech and diagnostic companies.
Comprehensive Quality Control System
Our quality control workflow spans raw material inspection, in-process testing, final verification, stability studies, and batch record reviews, ensuring every product meets defined specifications.
International Compliance & Regulatory Standards
Operating under ISO 13485-oriented manufacturing standards, we support global diagnostic partners with regulatory-ready production processes, GMP compliance, and continuous quality improvement systems.
Core Capabilities

Complete IVD Development Capabilities

Monoclonal Antibodies

High-specificity monoclonal antibodies developed for reliable performance across multiple IVD diagnostic applications.

Recombinant Antibodies

Engineered recombinant antibodies with excellent consistency, scalability, and batch-to-batch reproducibility.

Antigen Development

Custom antigen design and production services for assay development, validation, and diagnostic research.

POCT Development

Integrated POCT assay development solutions for rapid, sensitive, and user-friendly diagnostic testing platforms.

ELISA & CLIA Reagents

Optimized immunoreagents designed for ELISA and CLIA platforms with high sensitivity and stability.

OEM & CDMO Manufacturing

Flexible OEM and CDMO manufacturing services supporting pilot production and scalable commercial supply.
From antibody discovery and assay development to OEM manufacturing and scalable production, IVDCDMO delivers integrated solutions for global diagnostic companies across POCT, ELISA, CLIA, and FIA platforms. About Us
One-Stop In Vitro Diagnostics (IVD) CDMO Partner From Lab to Market
High-Affinity Antibodies for POCT, ELISA & CLIA Platforms

Precision IVD Antibodies for Diagnostic Success

We specialize in developing high-performance IVD antibodies and optimizing immunoassays for diagnostic manufacturers, biotech firms, and global IVD brands.
Proprietary CHO Cell Line Technology
Our proprietary CHO cell line platform enables stable expression, high affinity, and lot-to-lot consistency in antibody production across multiple IVD applications.
ISO 13485 Certified Manufacturing
From R&D to gram-scale production, our ISO 13485-oriented quality system ensures reliable manufacturing, regulatory readiness, and scalable supply for global diagnostic markets.

Technology & Platforms

Biomaterial, Technologies

Monoclonal & Polyclonal Antibody Preparation

Monoclonal & Polyclonal Antibody Preparation generates high-specificity binders for IVD, with custom antibody development optimized for multiple diagnostic immunoassay formats.
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Molecular Diagnostics, Platforms

NGS Library Prep CDMO Development

NGS Library Preparation builds core upstream workflows for molecular diagnostics, enabling high-fidelity sequencing across liquid biopsy and genetic testing. Our end-to-end CDMO optimizes reagents & protocols f
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ELISA, Platforms

ELISA Platform Enzyme-Linked Immunosorbent Assay

ELISA is a widely used technique for detecting and quantifying proteins, hormones, antibodies, and other antigens. Our antibodies are optimized for high-performance ELISA development.
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Immunoassay, Platforms

CLIA Platform Chemiluminescence Immunoassay

Chemiluminescence immunoassay (CLIA) offers the highest sensitivity among immunoassay formats, with detection limits in the femtogram/mL range. Our antibodies are optimized for CLIA systems.
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1
Countries Served
1
IVD Brands
1L
Production Capacity
1000
Laboratory area
1%
Client Satisfaction Rate
Rigorous Standards, Reliable Results: Your Trusted IVD Partner

Quality & Reliability at the Core of Every IVD Solution

Backed by ISO 13485-aligned processes and GMP-compliant facilities, we turn your diagnostic vision into trusted, market-ready solutions.
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End-to-End CDMO Partnership

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R&D & Innovation for Novel Diagnostics

IVD CDMO Company

State-of-the-Art Manufacturing

End-to-End IVD CDMO Solutions

Agile Solutions for Evolving Market

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Empowered Change,
Act, and to Adapt

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New Advanced
Instruments

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Strict Quality
Practices

ISO 13485 & Global Regulatory Support
Advanced Diagnostic Products for Global Healthcare Markets

End-to-End IVD Product Solutions

IVDCDMO connects global buyers with qualified manufacturers, scalable production resources, and integrated development capabilities for commercial diagnostic applications.
Comprehensive IVD product solutions covering chemiluminescence immunoassay (CLIA), molecular diagnostics, POCT systems, ELISA platforms, reagents, consumables, and laboratory instruments. More IVD Products
One-Stop IVD CDMO Partner for Global Diagnostic Brands

From Antibody Development to Mass Production — All in One Place

IVDCDMO provides integrated solutions for IVD antibody development, immunoreagent optimization, pilot production, and large-scale manufacturing for POCT, ELISA, CLIA, and FIA applications.
We support POCT, ELISA, CLIA, FIA, lateral flow assays, and other immunodiagnostic platforms with customized antibodies, antigens, and immunoreagent solutions.
Yes. We offer flexible OEM/ODM manufacturing solutions for global diagnostic brands and distributors.
Yes. From feasibility studies to pilot runs and mass production, we support projects at different development stages.
Development timelines vary depending on antibody type, assay platform, and validation requirements. Most projects move from feasibility study to pilot production within several weeks to a few months.
We develop monoclonal antibodies, polyclonal antibodies, recombinant antibodies, antigens, conjugates, and customized immunoreagents for various IVD applications.
Yes. We provide OEM/ODM manufacturing, technical documentation, batch consistency support, and ISO 13485-compliant production for global diagnostic brands and distributors.

Request a CDMO Consultation

Tell us about your project requirements. Our technical team will contact you within 24 hours.

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