Cell Marque Corp.

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Web: http://www.cellmarque.com
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Address: 6600 Sierra College Blvd., Rocklin, California 95677, USA
Phone: +1-(916)-746.8900 | Fax: +1-(916)-746.8989 | Map/Directions >>

Profile: Cell Marque Corp. focuses on producing and marketing antibodies primarily for diagnostic immunohistochemistry. We serve pathology laboratories and research facilities. We hold two patents; the first one describes a method that can serve to improve automation of diagnostic tests requiring a sequence of reagent applications to a specimen. The other serves to deparaffinize, rehydrate, and unmask biopsy specimens to prepare them for immunohistochemical staining. Our products include antibodies, detection systems, chromogens, buffers and pretreatment. Our Alpha-1-antichymotrypsin primary antibody reacts with histiocytes and histiocytic neoplasms. Its major application is defining the presence of Alpha-1-antichymotrypsin in histiocytes and tumors derived from them. In eosinophilic granuloma and malignant histiocytosis, the reaction for this marker is heterogeneous in intensity & distribution.

FDA Registration Number: 1649339

9 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:

• Cytokeratins (FDA Code: LYE / 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.

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

• General Purpose Reagent (FDA Code: LDT)

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

• Labeled Medical Laboratory Equipment (FDA Code: LXG / 862.2050)

General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.

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

• Progesterone Receptor Antibody Immunohistochemistry Assay (FDA Code: MXZ / 864.1860)

• 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.