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Immunologix Laboratories offer GLP and GCP compliant laboratory capabilities focused on biomarkers and bioanalysis of biologics, cell & gene therapy and nucleic acid based therapeutics. Our deep technical skills in ligand binding, cell-based and qPCR assays coupled with scientific consultation from our Translational Sciences team offers an integration of strategic, scientific and technical expertise that is unparalleled within our industry. This enables our team to deliver valuable scientific insights that accelerate decision-making and the overall course of drug development programs for our clients.
Quality systems compliant with GCP, GLP, EMA, FDA, OECD.
Based in the United States, serving clients globally (Americas, EU, Asia PAC).
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Trajan Scientific Americas Inc.
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Mitra® devices are intended as a specimen collector and for the storage and transport of blood. They are CE-IVD in the UK and EU, a Class 1 IVD in Australia, Brazil & China, Class B in South Africa, and registered with health agencies in Canada and Ukraine.
In the USA, Mitra devices are supplied as a Research-Use Only (RUO) product, to assist in method development, other research-related and non-diagnostic activities. Mitra has not been validated for use with any diagnostic testing. The suitability of Mitra for any analytical application must be evaluated and validated by the laboratory or research institute in a manner consistent with local regulatory requirements.
hemaPEN® is supplied for therapeutic or IVD use in Australia, New Zealand, UK, EU and USA only: ARTG number: 280007; CE mark, general IVD; US FDA number: D410490. Outside of the territories listed above, the hemaPEN is supplied for research use only (RUO) and not for therapeutic or diagnostic use.
Mitra®, VAMS® & hemaPEN® are registered trademarks owned by entities in the Trajan Group.
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