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Diagnostic BioSystems

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Contact: Bipin Gupta, Ph.D. - President & CEO
Web: http://dbiosys.com
E-Mail:
Address: 1020 Serpentine Lane, Suite # 114, Pleasanton, California 94566, USA
Phone: +1-(925)-484-3350, 888-896-3350 | Fax: +1-(925)-484-3390 | Map/Directions >>
 
 

Profile: Diagnostic BioSystems provides reagents for immunohistochemistry, for use in histopathology & cytopathology laboratories. We offer IVD, ASR and RUO labeled concentrated & pre-diluted ready-to-use antibodies. The alpha-Actinin, sarcomeric antibody is specific for alpha-skeletal muscle actinin, and alpha-cardiac actinin. It stains Z lines and dots in stress fibers of myotubes in skeletal & cardiac muscle, but not in non-sarcomeric muscle elements. It shows wide range of cross-reactivity with various mammalian tissues. The alpha-1-Antichymotrypsin antibody is specific against human alpha-1-antichymotrypsin. It stains monocytes and macrophages in human tissues & does not stain any other cell type. It shows cross-reactivity against wide range of mammalian tissues.

FDA Registration Number: 3007035884

13 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:
• Ancillary Reagents
• Concentrated Antibodies
• Custom Antibody Services
• Fluorescein Isothiocynate Conjugated Antibodies
• General Purpose Reagent (FDA Code: LDT)
• 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.
• Molecular Analyte Specific Reagents (ASR)
• pH Buffer (FDA Code: JCC / 864.4010)
• pH Buffer Calibration Solutions
• Quality Control Slide (FDA Code: LJG / 866.2660)
A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.
• Stain Kits
• Staining Detection Systems

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