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Beta 2-Glycoprotein I,Beta Globulin Control Suppliers & Manufacturers

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Beta 2-Glycoprotein I (FDA Code: DDN / 866.543)

Identification. Abeta -2-glycoprotein I immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thebeta -2-glycoprotein I (a serum protein) in serum and other body fluids. Measurement ofbeta -2-glycoprotein I aids in the diagnosis of an inherited deficiency of this serum protein.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 866.9.

Euroimmun Us Inc., Serbio

Beta Globulin Control (FDA Code: DCJ / 866.516)

Identification. Abeta -globulin immunological test system is a device that consists of reagents used to measure by immunochemical techniques beta globulins (serum protein) in serum and other body fluids.Beta -globulin proteins includebeta -lipoprotein, transferrin, glycoproteins, and complement, and are rarely associated with specific pathologic disorders.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 866.9.

Beckman Coulter, Inc., Interlab S.R.L.

Beta-2-Microglobulin Immunological Test System (FDA Code: JZG / 866.563)

Identification. Abeta -2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesbeta -2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement ofbeta -2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.

Classification. Class II (performance standards).

Teco Diagnostics, Diagnostic Automation, Inc., Biocheck, Inc., more...

Bladder Cancer Tumor Marker Test System (FDA Code: NAH)
Inverness Medical Innovations, Inc., Lyophilization Services Of New England, Inc., Operon, S.A.

Bladder Tumor Marker Monitoring Test (FDA Code: MMW / 866.601)

Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.

Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled "Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA," and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.

Polymedco Inc., Abbott Hematology, Abbott Laboratories, more...

Breast Cancer Rna Gene Expression Recurrence Risk Assessment Prognostic Classifier (FDA Code: NYI / 866.604)
Agendia Bv

C-Reactive Protein (CRP), FITC Conjugate (FDA Code: DCK / 866.527)

Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

Classification. Class II (performance standards).

Teco Diagnostics, Diagnostic Automation, Inc., Biocheck, Inc., more...

C-Reactive Protein Test System (FDA Code: DCN / 866.527)

Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

Classification. Class II (performance standards).

Teco Diagnostics, Biocheck, Inc., Abaxis, Inc, more...

Cancer 549 Antigen (FDA Code: MJB)
Biocheck, Inc.

Cancer Metastasis Detection Sentinel Lymph Node Rt-Pcr Multigene Expression Test (FDA Code: OCB)
Veridex, LLC

Carbohydrate Antigen (Ca19-9) Test System For Monitoring And Management Of Pancreatic Cancer (FDA Code: NIG / 866.601)

Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.

Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled "Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA," and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.

Siemens Healthcare Diagnostics, Ortho-clinical Diagnostics, Inc., Beckman Coulter, Inc., more...

Carbohydrate Antigen Test
Fujirebio Diagnostics Inc

Carcinoembryonic Antigen Test System (FDA Code: DHX / 866.601)

Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.

Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled "Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA," and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.

Biocheck, Inc., Siemens Healthcare Diagnostics, Ortho-clinical Diagnostics, Inc., more...

Cardiac C-Reactive Protein Antiserum Antigen Control (FDA Code: NQD / 866.527)

Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

Classification. Class II (performance standards).

Siemens Healthcare Diagnostics, Ortho-clinical Diagnostics, Inc., Beckman Coulter, Inc., more...

Ceruloplasmin (FDA Code: DDB / 866.521)

Identification. A ceruloplasmin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ceruloplasmin (copper-transporting serum protein) in serum, other body fluids, or tissues. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.

Classification. Class II (performance standards).

Siemens Healthcare Diagnostics, Dako North America, Inc., The Binding Site, more...

Ceruloplasmin Immunochemical (FDA Code: CHN / 866.521)

Identification. A ceruloplasmin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ceruloplasmin (copper-transporting serum protein) in serum, other body fluids, or tissues. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.

Classification. Class II (performance standards).

Siemens Healthcare Diagnostics, Roche Diagnostics Gmbh

Ceruloplasmin Indirect Copper Assay (FDA Code: JFR / 866.521)

Identification. A ceruloplasmin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ceruloplasmin (copper-transporting serum protein) in serum, other body fluids, or tissues. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.

Classification. Class II (performance standards).

Sentinel CH. SRL

CMV Donor Test (FDA Code: MZE)
Virotech International, Inc.

Complement C1q (FDA Code: DAK / 866.524)

Identification. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q, C1r, C1s, C2, C3, C4, C5, C6, C7, C8, and C9, in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

Classification. Class II (performance standards).

Bio-Rad Laboratories, Inc., Quidel Corporation, Inova Diagnostics, Inc., more...

Complement C1r (FDA Code: DAI / 866.524)

Identification. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q, C1r, C1s, C2, C3, C4, C5, C6, C7, C8, and C9, in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

Classification. Class II (performance standards).

The Binding Site

Complement C1s (FDA Code: CZY / 866.524)

Identification. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q, C1r, C1s, C2, C3, C4, C5, C6, C7, C8, and C9, in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

Classification. Class II (performance standards).

The Binding Site

Complement C1s (FDA Code: DBA / 866.525)

Identification. A complement C1inhibitor (inactivator) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the complement C1inhibitor (a plasma protein) in serum. Complement C1inhibitor occurs normally in plasma and blocks the action of the C1component of complement (a group of serum proteins which destroy infectious agents). Measurement of complement C1inhibitor aids in the diagnosis of hereditary angioneurotic edema (increased blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).

Classification. Class II (performance standards).

Quidel Corporation, Siemens Healthcare Diagnostics, The Binding Site, more...

Complement C3 (FDA Code: CZW / 866.524)

Identification. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q, C1r, C1s, C2, C3, C4, C5, C6, C7, C8, and C9, in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

Classification. Class II (performance standards).

Abbott Diagnostics, Siemens Healthcare Diagnostics, Scimedx Corporation, more...

Complement C3 Activator (FDA Code: DAC / 866.526)

Identification. A complement C3binactivator immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the complement C3binactivator (a plasma protein) in serum. Complement is a group of serum proteins that destroy infectious agents. Measurement of complement C3binactivator aids in the diagnosis of inherited antibody dysfunction.

Classification. Class II (performance standards).

Kent Laboratories, Inc.

Complement C3 Activator Immunoassay Reagent (FDA Code: KTP / 866.526)

Identification. A complement C3binactivator immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the complement C3binactivator (a plasma protein) in serum. Complement is a group of serum proteins that destroy infectious agents. Measurement of complement C3binactivator aids in the diagnosis of inherited antibody dysfunction.

Classification. Class II (performance standards).

Quidel Corporation

Complement C4 (FDA Code: DBI / 866.524)

Identification. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q, C1r, C1s, C2, C3, C4, C5, C6, C7, C8, and C9, in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

Classification. Class II (performance standards).

Abbott Diagnostics, Siemens Healthcare Diagnostics, Olympus America, Inc., more...

Complement C5 (FDA Code: DAY / 866.524)

Identification. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q, C1r, C1s, C2, C3, C4, C5, C6, C7, C8, and C9, in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

Classification. Class II (performance standards).

Dako North America, Inc., The Binding Site, Kent Laboratories, Inc., more...

Complement C8 (FDA Code: DAG / 866.524)

Identification. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q, C1r, C1s, C2, C3, C4, C5, C6, C7, C8, and C9, in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

Classification. Class II (performance standards).

The Binding Site

Complement C9 (FDA Code: DAE / 866.524)

Identification. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q, C1r, C1s, C2, C3, C4, C5, C6, C7, C8, and C9, in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

Classification. Class II (performance standards).

Wako Diagnostics, The Binding Site, The Binding Site Group Limited

Complement Protein (FDA Code: DHL / 866.41)

Identification. A complement reagent is a device that consists of complement, a naturally occurring serum protein from any warm-blooded animal such as guinea pigs, that may be included as a component part of serological test kits used in the diagnosis of disease.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 866.9.

Aalto Scientific Ltd, Dako North America, Inc., Beckman Coulter, Inc., more...

Complement Reagent (FDA Code: KTQ / 866.41)

Identification. A complement reagent is a device that consists of complement, a naturally occurring serum protein from any warm-blooded animal such as guinea pigs, that may be included as a component part of serological test kits used in the diagnosis of disease.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 866.9.

Invitrogen Corporation, Diamedix Corporation, The Binding Site, more...

Control Antigen Antinuclear Antibody (FDA Code: LKJ / 866.51)

Identification. 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).

Classification. Class II (performance standards).

Hycor Biomedical Inc., Bio-Rad Laboratories, Inc., Immuno Concepts N.A. Ltd., more...

Control Antiserum Antigen Alpha-1 Microglobulin (FDA Code: MGA / 866.54)

Identification. Analpha- globulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha- globulin (a serum protein) in serum and other body fluids. Measurement ofalpha- globulin may aid in the diagnosis of inflammatory lesions, infections, severe burns, and a variety of other conditions.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 866.9.

Kamiya Biomedical Company, Dako North America, Inc., The Binding Site, more...

Control Antiserum Antigen FC Test (FDA Code: DBN / 866.553)

Identification. An immunoglobulin G (Fc fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Fc (carbohydrate containing) fragment of immunoglobulin G (resulting from breakdown of immunoglobulin G antibodies) in urine, serum, and other body fluids. Measurement of immunoglobulin G Fc fragments aids in the diagnosis of plasma cell antibody-forming abnormalities, e.g., gamma heavy chain disease.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 866.9.

Dako North America, Inc., Antibodies, Inc., Kent Laboratories, Inc.

Control Antiserum Antigen Ferritin IGA (FDA Code: CZM / 866.551)

Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Classification. Class II (performance standards).

Dako North America, Inc., Kent Laboratories, Inc., Roche Diagnostics Gmbh

Control Antiserum Antigen Ferritin IGE (FDA Code: DFM / 866.551)

Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Classification. Class II (performance standards).

Dako North America, Inc., Kent Laboratories, Inc.

Control Antiserum Antigen Ferritin IGG (FDA Code: DGD / 866.551)

Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Classification. Class II (performance standards).

Dako North America, Inc., Clinical Controls International, Kent Laboratories, Inc.

Control Antiserum Antigen Ferritin IGM (FDA Code: DFL / 866.555)

Identification. 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.

Classification. Class II (performance standards).

Dako North America, Inc., Kent Laboratories, Inc.

Control Antiserum Antigen FITC FC Test (FDA Code: DBK / 866.553)

Identification. An immunoglobulin G (Fc fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Fc (carbohydrate containing) fragment of immunoglobulin G (resulting from breakdown of immunoglobulin G antibodies) in urine, serum, and other body fluids. Measurement of immunoglobulin G Fc fragments aids in the diagnosis of plasma cell antibody-forming abnormalities, e.g., gamma heavy chain disease.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 866.9.

Siemens Healthcare Diagnostics, Dako North America, Inc., Antibodies, Inc., more...

Control Antiserum Antigen Fitc Sperm (FDA Code: DFX / 866.58)

Identification. A seminal fluid (sperm) immunological test system is a device that consists of the reagents used for legal purposes to identify and differentiate animal and human semen. The test results may be used as court evidence in alleged instances of rape and other sex-related crimes.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 866.9.

DRG International, Inc.

Control Antiserum Antigen FITC Thyroglobulin (FDA Code: DDJ / 866.587)

Identification. A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.

Classification. Class II (performance standards).

Hemagen Diagnostics, Inc.

Control Antiserum Antigen Lactic Dehydrogenase Test (FDA Code: DET / 866.556)

Identification. A lactic dehydrogenase immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the activity of the lactic dehydrogenase enzyme in serum. Increased levels of lactic dehydrogenase are found in a variety of conditions, including megaloblastic anemia (decrease in the number of mature red blood cells), myocardial infarction (heart disease), and some forms of leukemia (cancer of the blood-forming organs). However, the diagnostic usefulness of this device is limited because of the many conditions known to cause increased lactic dehydrogenase levels.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 866.9.

Beckman Coulter, Inc.

Control Antiserum/Antigen
Kronus, Inc., Vector Laboratories, Inc., Antibodies, Inc., more...

Cytokeratins (FDA Code: LYE / 866.555)

Identification. 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.

Classification. Class II (performance standards).

Invitrogen Corporation, Becton, Dickson & Co.,, Cell Marque Corp., more...

Dna Genetics Quality Control Material (FDA Code: NZB / 866.591)
Precision System Science USA, Inc., Maine Molecular Quality Controls, Paragondx, Llc

DNA-Probe Cancer Detection Test
Affymetrix, Abbott Laboratories,, Vysis UK Ltd., more...

Electrophoresis Instrumentation (FDA Code: JZS / 866.45)

Identification. Immunoelectrophoresis equipment for clinical use with its electrical power supply is a device used for separating protein molecules. Immunoelectrophoresis is a procedure in which a complex protein mixture is placed in an agar gel and the various proteins are separated on the basis of their relative mobilities under the influence of an electric current. The separated proteins are then permitted to diffuse through the agar toward a multispecific antiserum, allowing precipitation and visualization of the separate complexes.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 866.9.

Bio-Rad Laboratories, Inc., ISS, Inc., Siemens Healthcare Diagnostics, more...

Endomysial Autoantibodies (FDA Code: MVM / 866.566)

Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).

Classification. Class II (performance standards).

Diagnostic Automation, Inc., Hycor Biomedical Inc., Sunmedica, Inc., more...

Enzyme Labeled Anti-DNA Antibody (FDA Code: LRM / 866.51)

Identification. 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).

Classification. Class II (performance standards).

Diagnostic Automation, Inc., Hycor Biomedical Inc., Bio-Rad Laboratories, Inc., more...

Enzyme Labeled Antinuclear Antibody (FDA Code: LJM / 866.51)

Identification. 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).

Classification. Class II (performance standards).

Teco Diagnostics, Diagnostic Automation, Inc., Hycor Biomedical Inc., more...

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