Profile: Genemed Biotechnologies, Inc. offers contract development and manufacturing services for the pharmaceutical & diagnostic companies. We offer a range of antigen retrieval reagents, substrates, and buffers to facilitate staining processes. Our product range includes pre-treatment buffers & enzymes, blocking solutions, diluents, chromogens, counterstains, mounting media, and general buffers which are used in routine immunohistochemistry (IHC) testing. We provide clinical relevant primary antibodies, in ready to use or concentrate forms, monoclonal or polyclonal, from mouse or rabbit. We also provide non-immune controls from mouse or rabbit. Our primary antibodies for IHC are in liquid form and contain an antimicrobial agent. Our primary antibodies are optimized and titrated for IHC testing using human formalin-fixed, paraffin-embedded (FFPE) tissue sections along with our IHC detection & ancillary reagents.
The company is ISO-13485:2003 certified.
FDA Registration Number: 2939340
9 Products/Services (Click for related suppliers)
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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: |
| • Antigen Retrieval Reagents |
| • Antigen-Antibody Pen For Mouse Primary antibodies |
| • Antigen-Antibody Pen For Rabbit Primary antibodies |
| • Detection Systems |
| • Ihc Her-2/Neu Test System (FDA Code: MVC) |
| • 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. |
| • Primary Antibodies |
| • Ventricular (Containing Antibiotic Or Antimicrobial Agents) Catheter (FDA Code: NHC / 882.4100) A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain. |