Profile: Ventana Medical Systems, Inc. deals with diagnostic instruments and reagent systems for use in slide-based diagnosis of cancer and infectious disease. Our products are found in hospital-based histology laboratories, independent reference laboratories, and the drug discovery laboratories of pharmaceutical & biotechnology companies, government labs, & medical research centers. Our Symphony™ system completely automates every step of slide preparation with one touch operation from drying through the application of a glass coverslip. The slides can be cured immediately and are available pathologist interpretation. Our Vias™ is an easy-to-use, desktop system that readily shifts between computer assisted image analysis and routine microscopy to maximize system flexibility & utilization. It seamlessly integrates into the pathologist's current workflow to accommodate real-time image capture and quantitation of percent-positive cells. Our instrument-reagent systems are designed to standardize the preparation and staining of patient tissue or cells mounted on a microscope slide for examination by a pathologist.

The company was founded in 1991, has ~950 employees. NASDAQ:VMSI (SEC Filings)

FDA Registration Number: 2028492

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• Acid Containing Fixative (FDA Code: LDW / 864.4010)

• Alcian Blue Stain (FDA Code: IDA / 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.

• Alcohol Containing Fixative (FDA Code: LDZ / 864.4010)

• Alpha-1-Antitrypsin (FDA Code: DEM / 866.5130) Analpha -1-antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha -1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition,alpha -1-antitrypsin deficiency has been associated with pulmonary emphysema.

• Ammoniacal Silver Hydroxide Silver Nitrate Stain (FDA Code: ICZ / 864.1850)

• Amplication Kit

• 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:

• Anti Biotin Mab

• Anti Mouse IgG

• Antibody Diluent

• 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 Stainer (FDA Code: KEY / 864.3800)

• C-Kit Immunohistochemistry Antibody Assay (FDA Code: NKF / 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.

• Cancer Test Kits

• Carbol Fuchsin Stain (FDA Code: ICL / 864.1850)

• Compliance Service, FDA

• Congo Red Stain (FDA Code: ICH / 864.1850)

• 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.

• Cytology Equipment Stainers

• Cytology Test Stains

• Desiccant Filter

• Diastase (FDA Code: IBC / 864.4400) Enzyme preparations are products that are used in the histopathology laboratory for the following purposes:

• Dye Solution Stain (FDA Code: LEE / 864.1850)

• Endogenous Biotin Blocking Kit

• Estrogen Receptor Antibody Immunohistochemistry Assay (FDA Code: MYA / 864.1860)

• Ethyl Eosin (FDA Code: KJS / 864.1850)

• Formulations Paraffin (FDA Code: KEO / 864.4010)

• General Purpose Reagent (FDA Code: LDT)

• Giemsa Stain (FDA Code: HYF / 864.1850)

• Hematoxylin Stain (FDA Code: HYJ / 864.1850)

• Hematoxylin Stain Solution with Phosphotungstic Acid

• Histology Test Kits

• Human Chromosome DNA-Probe (FDA Code: MAO)

• Human Papillomavirus DNA Detection Kit (FDA Code: MAQ)

• Ihc Her-2/Neu Test System (FDA Code: MVC)

• Immunoassay Reagents & Test Kits

• Immunohistochemistry Reagents And Kits (FDA Code: NJT / 864.1860)

• Infectious Disease Identification Test Kits

• Instruments, Immunoassays

• Iron Stain (FDA Code: GGH / 864.1850)

• Laboratory Automation Systems

• Lambda Antiserum (FDA Code: DEH / 866.5550) An immunoglobulin (light chain specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques both kappa and lambda types of light chain portions of immunoglobulin molecules in serum, other body fluids, and tissues. In some disease states, an excess of light chains are produced by the antibody-forming cells. These free light chains, unassociated with gamma globulin molecules, can be found in a patient's body fluids and tissues. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.

• Laser Surgical Systems, Laser Illumination Probes

• Light Green Stain (FDA Code: HYS / 864.1850)

• Mallory's Trichrome Stain (FDA Code: HYW / 864.1850)

• Mayer's Hematoxylin Stain (FDA Code: HYL / 864.1850)

• Methenamine Silver Stain (FDA Code: HYZ / 864.1850)

• Methyl Green Stain (FDA Code: HZA / 864.1850)

• Microbial Detection Systems

• Mini-Lacrimal Probes