BD Diagnostics - TriPath

Address: 780 Plantation Drive, Burlington, North Carolina 27215, USA
Phone: +1-(336)-222-9707 | Fax: +1-(336)-222-8819 | Map/Directions >>

Profile: BD Diagnostics - TriPath develops and distributes solutions to improve the clinical management of cancer, including detection, diagnosis, staging and treatment. Our BD ProEx™ C reagent is a highly sensitive and specific biomarker reagent used with standard immunocytochemistry (ICC) and immunohistochemistry (IHC) techniques to detect the presence of aberrant S-Phase induction. Our BD SMS 3600™ molecular stainer provides cytology labs with a convenient platform that can be used to automate manual staining procedures. It is compatible with any currently available reagents for ICC & IHC related applications. Our BD SureDetect™ general purpose reagents are high quality general use reagents intended for use with immunocytochemistry (ICC) and immunohistochemistry (IHC) procedures in manual or automated staining procedures.

FDA Registration Number: 1062336

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• Alcohol Containing Fixative (FDA Code: LDZ / 864.4010)
• 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:
• Automated Cervical Cytology Slide Reader (FDA Code: MNM)
• Automated Cytology Slide Processor (FDA Code: MKQ)
• Automated Slide Stainer (FDA Code: KPA / 864.3800)
An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis.
• Automated Tissue Processor (FDA Code: IEO / 864.3875)
An automated tissue processor is an automated system used to process tissue specimens for examination through fixation, dehydration, and infiltration.
• Blood Analyzer Reagents
• Calibration Equipment
• Calibrators
• Calibrators for Equipment
• Chemistry Analyzers
• Clinical Diagnostic Solutions, Hematology Reagents
• Clinical Immunochemistry Analyzers
• Coagulation Lab Testing
• Controls
• Controls for Diagnostic Equipment
• Cultured Animal and Human Cells (FDA Code: KIR / 864.2280)
Cultured animal and human cells are in vitro cultivated cell lines from the tissue of humans or other animals which are used in various diagnostic procedures, particularly diagnostic virology and cytogenetic studies.
• Cytocentrifuge (FDA Code: IFB / 864.3300)
A cytocentrifuge is a centrifuge used to concentrate cells from biological cell suspensions (e.g., cerebrospinal fluid) and to deposit these cells on a glass microscope slide for cytological examination.
• Cytological Preservative (FDA Code: LEA / 864.4010)
• Diagnostic Aids
• Digoxin Calibrators
• Drug Calibrator
• Drug Monitoring Calibrator
• Dye Solution Stain (FDA Code: LEE / 864.1850)
Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.
• Enzyme Labeled Antinuclear Antibody (FDA Code: LJM / 866.5100)
An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjogren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).
• General Diagnostic Supplies
• General Diagnostics
• General Examination Supplies
• General Medical Supplies
• General Purpose Reagent (FDA Code: LDT / 864.4010)
• Hematology Reagents
• Hematology Reagents and Kits
• Hematology Reagents and Kits Hemoglobin A1C (Glycohemoglobin)
• Hematology Reagents and Supplies
• Immuno Chemistry Analyzers
• Immunoassay Equipment, Immunochemistry Analyzers
• Mechanical Calibration Kit
• Microscope Slide Boxes
• Microscope Slide Dispenser
• Microscope Slide Drawer
• Microscope Slide Staining Kit
• Microscope Slide Storage Cabinets
• Microscope Slides (FDA Code: KEW / 864.3010)
Tissue processing equipment consists of devices used to prepare human tissue specimens for diagnostic histological examination by processing specimens through the various stages of decalcifying, infiltrating, sectioning, and mounting on microscope slides.
• Microscope Slides (FDA Code: KEW / 864.3010)
• Molecular Analyte Specific Reagents (ASR)
• Multi Analyte Control (FDA Code: JJY / 862.1660)
A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.
• pH Buffer (FDA Code: JCC / 864.4010)
• pH Buffer Calibration Solutions
• Storage Racks for Microscope Slide Boxes
• Temperature Calibrator

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