Profile: Dxs Limited is a personalised medicine company providing molecular diagnostics to aid doctors and drug companies in selecting therapies for patients. We help in treatment of cancer by providing biomarkers and companion diagnostics, personalised medicine, companion diagnositcs, oncology biomarkers, molecular diagnostics. We provide diagnostic and research kits that detect mutations in oncogenes. Our product therascreenr range of diagnostic products includes kits that detect mutations in the EGFR and K-RAS genes. Tumour mutation products are available for research use for EGFR, K-RAS, B-RAF, PI3K, BCR-ABL. We also provide a genetic analysis service to support clinical development.
The company is ISO 13485, ISO 9001 certified.
FDA Registration Number: 3005118020
US Agent: Lindsey Howard / Qiagen Sciences Llc
Phone: +1-(240)-686-7826 Fax: +1-(240)-686-7827 E-Mail:
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• Analyte Specific Reagents, Asr Reagents (FDA Code: MVU / 864.4020) Analyte specific reagents (ASR's) are antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens. ASR's that otherwise fall within this definition are not within the scope of subpart E of this part when they are sold to: |