Acetylcholine Blocking And Non-Blocking Acetylcholine Receptor Autoantibodies,Albumin Antigen Antiserum Control Suppliers & Manufacturers

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Acetylcholine Blocking And Non-Blocking Acetylcholine Receptor Autoantibodies (FDA Code: NST / 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).

Kronus, Inc., DRG International, Inc., IVD Technologies, more...

Albumin Antigen Antiserum Control (FDA Code: DCF / 866.504)

Identification. An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.

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

Siemens Healthcare Diagnostics, Genzyme Biosurgery, Ortho-clinical Diagnostics, Inc., more...

Albumin, FITC Conjugate (FDA Code: DDZ / 866.504)

Identification. An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.

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

Siemens Healthcare Diagnostics, Pointe Scientific, Inc., Polymedco Inc., more...

Allergy Syringe
Inviro Medical, Becton, Dickson & Co.,, Dealmed Medical Supplies, more...

Allergy Test
Hycor Biomedical Inc., Biomerica, Quidel Corporation, more...

Alpha Fetoprotein L3 Subfraction (Afp-L3%) Test For Hepatocellular Carcinoma Risk Assessment (FDA Code: NSF / 866.603)
Wako Diagnostics, Monobind Inc., Furuno Electric Co., Ltd.

Alpha-1-Acid-Glycoprotein Antigen (FDA Code: LKL / 866.542)

Identification. Analpha- 1-glycoproteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesalpha- 1-glycoproteins (a group of plasma proteins found in thealpha- 1 group when subjected to electrophoresis) in serum and other body fluids. Measurement of specificalpha- 1-glycoproteins may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes.

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.

Siemens Healthcare Diagnostics, Olympus America, Inc., Kamiya Biomedical Company, more...

Alpha-1-Antichymotrypsin (FDA Code: DFF / 866.508)

Identification. Analpha -1-antichymotrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesalpha -1-antichymotrypsin (a protein) in serum, other body fluids, and tissues.Alpha -1-antichymotrypsin helps protect tissues against proteolytic (protein-splitting) enzymes released during infection.

Classification. Class II (performance standards).

Dako North America, Inc., The Binding Site

Alpha-1-Antitrypsin (FDA Code: DEM / 866.513)

Identification. 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.

Classification. Class II (performance standards).

Ventana Medical Systems, Inc., Siemens Healthcare Diagnostics, Olympus America, Inc., more...

Alpha-1-B-Glycoprotein Antiserum Antigen Control (FDA Code: DEX / 866.542)

Identification. Analpha- 1-glycoproteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesalpha- 1-glycoproteins (a group of plasma proteins found in thealpha- 1 group when subjected to electrophoresis) in serum and other body fluids. Measurement of specificalpha- 1-glycoproteins may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes.

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.

Siemens Healthcare Diagnostics, DRG International, Inc.

Alpha-1-Lipoprotein (FDA Code: DER / 866.558)

Identification. Analpha -1-lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha- 1-lipoprotein (high-density lipoprotein) in serum and plasma. Measurement ofalpha- 1-lipoprotein may aid in the diagnosis of Tangier disease (a hereditary disorder of fat metabolism).

Classification. Class II (performance standards).

Hemagen Diagnostics, Inc., Kamiya Biomedical Company, Carolina Liquid Chemistries Corp., more...

Alpha-1-T-Glycoprotein (FDA Code: DEN / 866.542)

Identification. Analpha- 1-glycoproteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesalpha- 1-glycoproteins (a group of plasma proteins found in thealpha- 1 group when subjected to electrophoresis) in serum and other body fluids. Measurement of specificalpha- 1-glycoproteins may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes.

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.

The Binding Site

Alpha-2-AP-Glycoprotein (FDA Code: DAW / 866.5425)

Identification. Analpha -2-glycoproteins immunolgical test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha -2-glycoproteins (a group of plasma proteins found in thealpha- 2 group when subjected to electrophoresis) in serum and other body fluids. Measurement ofalpha -2-glycoproteins aids in the diagnosis of some cancers and genetically inherited deficiencies of these plasma proteins.

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.

The Binding Site

Alpha-2-Glycoproteins (FDA Code: DEJ / 866.5425)

Identification. Analpha -2-glycoproteins immunolgical test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha -2-glycoproteins (a group of plasma proteins found in thealpha- 2 group when subjected to electrophoresis) in serum and other body fluids. Measurement ofalpha -2-glycoproteins aids in the diagnosis of some cancers and genetically inherited deficiencies of these plasma proteins.

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.

The Binding Site, Serbio

Alpha-2-HS-Glycoprotein (FDA Code: DEF / 866.5425)

Identification. Analpha -2-glycoproteins immunolgical test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha -2-glycoproteins (a group of plasma proteins found in thealpha- 2 group when subjected to electrophoresis) in serum and other body fluids. Measurement ofalpha -2-glycoproteins aids in the diagnosis of some cancers and genetically inherited deficiencies of these plasma proteins.

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.

Remel, Olympus America, Inc., Beckman Coulter, Inc., more...

Alpha-2-Macroglobulin (FDA Code: DEB / 866.562)

Identification. Analpha -2-macroglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha -2-macroglobulin (a serum protein) in plasma. Measurement ofalpha -2-macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders.

Classification. Class II (performance standards).

Siemens Healthcare Diagnostics, Dako North America, Inc., International Immunology Corp., more...

Alpha-Fetoprotein for Testicular Cancer Test Kit (FDA Code: LOJ / 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.

Diagnostic Automation, Inc., Biocheck, Inc., Siemens Healthcare Diagnostics, more...

Alpha-Fetoprotein RIA Test System (FDA Code: KTJ)
Princeton BioMeditech Corp., Ameritek U.S.A.

Alpha-Fetoprotein Test for Neural Tube Defect Test (FDA Code: LOK)
Siemens Healthcare Diagnostics, PerkinElmer, Inc.(LAS), Beckman Coulter, Inc., more...

Alpha-Globulin Antiserum Antigen Control (FDA Code: DCO / 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.

Siemens Healthcare Diagnostics, Beckman Coulter, Inc., Amico Laboratories Inc.

Anti IgD FITC (FDA Code: DGG / 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).

Biosource International, Dako North America, Inc.

Anti IgE FITC (FDA Code: DGP / 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).

Biosource International, Dako North America, Inc., Antibodies, Inc., more...

Anti IgG FITC (FDA Code: DGK / 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).

Biosource International, Hemagen Diagnostics, Inc., Immco Diagnostics, more...

Anti IGG Rhodamine Conjugated (FDA Code: DFO / 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).

Biosource International, Dako North America, Inc.

Anti-Cyclic Citrullinated Peptide (Ccp) Antibodies (FDA Code: NHX / 866.5775)

Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.

Classification. Class II (performance standards).

Inova Diagnostics, Inc., Euroimmun Us Inc., Axis-Shield Diagnostics, Ltd., more...

Anti-DNA Indirect Immunofluorescent Solid Phase (FDA Code: KTL / 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).

Immuno Concepts N.A. Ltd., Hemagen Diagnostics, Inc., The Binding Site, more...

Anti-IgM FITC-Conjugated (FDA Code: DFS / 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).

Biosource International, Dako North America, Inc., Antibodies, Inc., more...

Anti-kappa Antiserum (FDA Code: DFH / 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).

Biosource International, Siemens Healthcare Diagnostics, Helena Laboratories Corp., more...

Anti-kappa Rhodamine-conjugated (FDA Code: DEK / 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.

Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody Autoantibodies (FDA Code: NYO / 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).

Inova Diagnostics, Inc., Mbl International Corporation

Anti-Ribosomal P Antibodies (FDA Code: MQA / 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., Bio-Rad Laboratories, Inc., Inova Diagnostics, Inc., more...

Anti-RNP Antibody (FDA Code: LKO / 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., Innominata dba GenBio, more...

Anti-SM-Antibody (FDA Code: LKP / 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., Innominata dba GenBio, more...

Anti-Smooth Muscle Anti-Actin Antibodies (FDA Code: NJF / 866.512)

Identification. An antismooth muscle antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the antismooth muscle antibodies (antibodies to nonstriated, involuntary muscle) in serum. The measurements aid in the diagnosis of chronic hepatitis (inflammation of the liver) and autoimmune connective tissue diseases (diseases resulting from antibodies produced against the body's own tissues).

Inova Diagnostics, Inc.

Anti-Ss-A 52 Autoantibodies (FDA Code: OBE / 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).

Inova Diagnostics, Inc.

Antibodies to Glomerular Basement Membrane (gbm) Measure Devices (FDA Code: MVJ / 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).

Hycor Biomedical Inc., Bio-Rad Laboratories, Inc., Inova Diagnostics, Inc., more...

Antigen and Control Anti-DNA Antibody (FDA Code: LSW / 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).

Sunmedica, Inc., Diamedix Corporation, Immco Diagnostics, more...

Antigen And Control Extractable Antinuclear Antibody (FDA Code: LLL / 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...

Antineutrophil Cytoplasmic Antibodies (ANCA) Test System (FDA Code: MOB / 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., Bio-Rad Laboratories, Inc., more...

Antinuclear Antibody, Indirect Immunofluorescen (FDA Code: DHN / 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., Bio-Rad Laboratories, Inc., Sunmedica, Inc., more...

Antiparietal Cell Antibody Antigen Control, Enzyme Immunoassay (FDA Code: MLE / 866.511)

Identification. An antiparietal antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the specific antibody for gastric parietal cells in serum and other body fluids. Gastric parietal cells are those cells located in the stomach that produce a protein that enables vitamin B12to be absorbed by the body. The measurements aid in the diagnosis of vitamin B12deficiency (or pernicious anemia), atrophic gastritis (inflammation of the stomach), and autoimmune connective tissue diseases (diseases resulting when the body produces antibodies against its own tissues).

Classification. Class II (performance standards).

Hycor Biomedical Inc., Inova Diagnostics, Inc.

Antithrombin III Control (FDA Code: DDQ / 864.706)

Identification. An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).

Classification. Class II (performance standards).

Mardx Diagnostics, Inc., Dako North America, Inc., International Immunology Corp., more...

Autoimmune Disease K-Nearest Neighbor Algorithm Diagnostic Software (FDA Code: NVI / 862.31)

Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

Classification. Class II.

Bio-Rad Laboratories, Inc.

Autoimmune Hepatitis Anti-Soluble Liver Antigen (Sla) Autoantibodies (FDA Code: NIY / 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).

Inova Diagnostics, Inc.

Automated Bloodborne Pathogen Test Equipment (FDA Code: MZA)
Gen-probe Incorporated, Ortho-clinical Diagnostics, Inc., Abbott Hematology

Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays System (FDA Code: NTH / 866.47)
Applied Imaging Corp., Abbott Hematology, Ikonisys, Inc, more...

B2 - Glycoprotein I Antibodies Test System (FDA Code: MSV / 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).

Hycor Biomedical Inc., Inova Diagnostics, Inc., Corgenix, Inc., more...

Bacterial Detection System For Platelet Transfusion Products (FDA Code: MZC / 866.256)
Medsep Corp., A Subsidiary Of Pall Corp., Verax Biomedical Incorporated, Ensatec, S.A. De C.V.

Bence-Jones Protein (FDA Code: CZQ / 866.515)

Identification. A Bence-Jones proteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Bence-Jones proteins in urine and plasma. Immunoglobulin molecules normally consist of pairs of polypeptide chains (subunits) of unequal size (light chains and heavy chains) bound together by several disulfide bridges. In some cancerous conditions, there is a proliferation of one plasma cell (antibody-producing cell) with excess production of light chains of one specific kind (monoclonal light chains). These free homogeneous light chains not associated with an immunoglobulin molecule can be found in urine and plasma, and have been called Bence-Jones proteins. Measurement of Bence-Jones proteins and determination that they are monoclonal aid in the diagnosis of multiple myeloma (malignant proliferation of plasma cells), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins by spleen and bone marrow cells), leukemia (cancer of the blood-forming organs), and lymphoma (cancer of the lymphoid tissue).

Classification. Class II (performance standards).

Biosource International, The Binding Site, Kent Laboratories, Inc.

Bence-Jones Protein Immunochemical (FDA Code: JKM / 866.515)

Identification. A Bence-Jones proteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Bence-Jones proteins in urine and plasma. Immunoglobulin molecules normally consist of pairs of polypeptide chains (subunits) of unequal size (light chains and heavy chains) bound together by several disulfide bridges. In some cancerous conditions, there is a proliferation of one plasma cell (antibody-producing cell) with excess production of light chains of one specific kind (monoclonal light chains). These free homogeneous light chains not associated with an immunoglobulin molecule can be found in urine and plasma, and have been called Bence-Jones proteins. Measurement of Bence-Jones proteins and determination that they are monoclonal aid in the diagnosis of multiple myeloma (malignant proliferation of plasma cells), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins by spleen and bone marrow cells), leukemia (cancer of the blood-forming organs), and lymphoma (cancer of the lymphoid tissue).

Classification. Class II (performance standards).

Sebia Electrophoresis

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