Profile: Diarect Ag provides immunodiagnostic test systems. We are an ISO 9001:2001and ISO 13485 certified company. We offer autoimmune antigens, immunoassay substrates and stabilization products. Thyroid peroxidase (TPO) represents the main auto antigenic targets in autoimmune thyroid disease of humans. We produce a truncated soluble TPO molecule, which consists of the epitope-bearing extracytoplasmic domain. The recombinant production of an engineered TPO antigen eliminates the purity problems of the classical microsomal antigen preparations, which are inevitably contaminated with thyroglobulin, a major thyroid autoantigen. The StabilCoat® Plus microarray stabilizer improves the stability of proteins bound to microspheres stored in solution, and array proteins stored in the dried state. The StabilZyme® HRP conjugate stabilizer is developed specifically for Horseradish Peroxidase (HRP) conjugates in solution. The StabilZyme HRP stabilizer is readily incorporated into virtually any assay production protocol. The conjugates can be added directly to StabilZyme HRP stabilizer and are then ready for storage and use. They are also good diluents & often decrease background and increase signal for improved signal-to-noise ratios.
The company is ISO 9001:2001, ISO 13485 certified.
FDA Registration Number: 3003408248
US Agent: Shawn Fuller / Surmodics, Inc.
Phone: +1-(952)-500-7090 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: |