Ivd Research, Inc.


IVD Research, Inc. is a contract development and manufacturing (CDMO) firm specializing in the development, manufacture, and marketing of high-performance diagnostics and laboratory solutions. Established in 1996, the company is committed to providing high-quality, reliable products, tools, and services for global pathogen detection across multiple technologies. They operate under strict regulatory standards including ISO 13485 certification and FDA registration, ensuring compliance with cGMPs. Their mission is to deliver innovative, accurate, and consistent diagnostic products, supporting clients from R&D to commercialization with custom-tailored solutions.

Industries

health-diagnostics
manufacturing
medical-device

Nr. of Employees

small (1-50)

Ivd Research, Inc.

5909 Sea Lion Place, Ste D, Carlsbad, Ca, 92010 USA


Products

Microwell ELISA test kits (antigen and antibody detection)

Microwell ELISA kits for antigen detection from stool and urine and for antibody detection from serum; offered for multiple pathogens.

Direct fluorescent antigen (DFA) test kit for stool

Direct immunofluorescence assay kit for detection and morphological differentiation of Cryptosporidium and Giardia in stool (kit contains 75 tests).

Lateral flow immunoassay product line

Rapid lateral flow test kits designed for point-of-care or in-office use across multiple sample types and targets.

External control and quality materials

External control products and QC materials intended to support validation and routine quality control of diagnostic assays.


Services

Contract design, development, manufacture and OEM supply of diagnostic tests and turnkey laboratory products for human and veterinary applications.

Custom-tailored packages to support specific manufacturing stages or full lifecycle support from R&D through commercialization and scale-up.

Manufacturing operations and quality management designed to meet current Good Manufacturing Practices and regulatory requirements for diagnostics.

Assay design, reagent development, and post-launch technical/customer support for diagnostic products.

Expertise Areas

  • In vitro diagnostic (IVD) development
  • Microwell ELISA development
  • Lateral flow assay development
  • Direct immunofluorescence (DFA) diagnostics
  • Show More (4)

Key Technologies

  • Enzyme-linked immunosorbent assay (ELISA)
  • Lateral flow immunoassay
  • Direct immunofluorescence assay (DFA)
  • Automated precision liquid dispensing for membranes
  • Show More (2)

News & Updates

The company upgraded to a BioDot XYZ3210 dispensing platform, increasing production speed and efficiency, enabling faster delivery of veterinary diagnostic products.

IVD Research licensed a novel biomarker for onchocerciasis from Scripps Research, aiding in monitoring active infections of river blindness.


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