Profile: Epitomics, Inc. specializes in the production of rabbit monoclonal antibodies using proprietary RabMAb technology. Our product line includes blocking peptides, control cell lysate, secondary antibodies, isotype controls and media & buffers.
FDA Registration Number: 3008363390
2 Products/Services (Click for related suppliers)
|
• 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: |
• Immunohistochemistry Reagents And Kits (FDA Code: NJT / 864.1860) Immunohistochemistry test systems (IHC's) are in vitro diagnostic devices consisting of polyclonal or monoclonal antibodies labeled with directions for use and performance claims, which may be packaged with ancillary reagents in kits. Their intended use is to identify, by immunological techniques, antigens in tissues or cytologic specimens. Similar devices intended for use with flow cytometry devices are not considered IHC's. |