Profile: Helena Laboratories Corp. develops new diagnostic tests. We manufacture electrophoresis analyzers, test kits for fecal occult blood, immunology and protein diagnostics, and hemostasis reagents & instruments. Our quickscan 2000 uses flat-bed densitometry to image visible electrophoretic analytes on agarose gels, with the speed of windows, and the ease of Helena technology. Our AggRam analyzer includes CPU with CD burner, keyboard, mouse, color ink-jet printer and one AggRam module. It is used for platelet aggregation and ristocetin co-factor testing, and offers unsurpassed precision, ease of use and flexibility.

The company was founded in 1966, has revenues of USD 50-100 Million, has ~1000 employees and is ISO 9001, CE certified. NYSE:ASD (SEC Filings)

FDA Registration Number: 3011390138

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• Hemolysate Reagent

• Heparin Assay (FDA Code: KFF / 864.7525) A heparin assay is a device used to determine the level of the anticoagulant heparin in the patient's circulation. These assays are quantitative clotting time procedures using the effect of heparin on activated coagulation factor X (Stuart factor) or procedures based on the neutralization of heparin by protamine sulfate (a protein that neutralizes heparin).

• IGA Control (FDA Code: CZP / 866.5510) 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.

• IgD Antisera (FDA Code: CZJ / 866.5510)

• IgE Control (FDA Code: DGC / 866.5510)

• Immunodiffusion Equipment

• Immunoelectrophoretic, Immunoglobulins (G, A, M) (FDA Code: CFF / 866.5510)

• Immunoglobulin M (IgM) (FDA Code: DFT / 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.

• Isoenzymes Colorimetric Method (FDA Code: JHY / 862.1215) A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

• Isoenzymes Fluorometric Method (FDA Code: JHX / 862.1215)

• Laboratory Coagulation Analyzers

• Laboratory Densitometer

• Laboratory Equipment

• Laboratory Equipment Devices

• Labware, Pipette Tip

• Lactate Dehydrogenase 4-dinitrophenylhydrazine 2 (FDA Code: CER / 862.1440) A lactate dehydrogenase test system is a device intended to measure the activity of the enzyme lactate dehydrogenase in serum. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys.

• Lambda Antiserum (FDA Code: DEH / 866.5550)

• Lipoproteins Electrophoretic Separation Test (FDA Code: JHO / 862.1475) A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

• Micro Pipette (FDA Code: JRC / 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.

• Micro Pipette Tips and Tip Racks

• Microdispenser

• Mu-chain Specific Antisera (FDA Code: DAO / 866.5550)

• 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.

• Multipurpose System for Invitro Coagulation Studies (FDA Code: JPA / 864.5425) A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

• Non-Barrier Pipette Tip, Racked

• Non-Sterile Barrier Pipette Tips

• Normal Control Plasma (FDA Code: GIZ / 864.5425)

• Occult Blood Reagent (FDA Code: KHE / 864.6550) An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)

• Ouchterlony Agar Plate Test (FDA Code: JZP / 866.4600) An ouchterlony agar plate for clinical use is a device containing an agar gel used to examine antigen-antibody reactions. In immunodiffusion, antibodies and antigens migrate toward each other through gel which originally contained neither of these reagents. As the reagents come in contact with each other, they combine to form a precipitate that is trapped in the gel matrix and is immobilized.

• Partial Thromboplastin Test Time (FDA Code: GGW / 864.7925) A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.

• Pasteur Pipettes (FDA Code: GJW / 864.6160) A manual blood cell counting device is a device used to count red blood cells, white blood cells, or blood platelets.

• pH Buffer (FDA Code: JCC / 864.4010)

• pH Buffer Calibration Solutions

• Pipette Tip Disposal Box

• Pipetting and Diluting Station (FDA Code: JQW / 862.2750) A pipetting and diluting system for clinical use is a device intended to provide an accurately measured volume of liquid at a specified temperature for use in certain test procedures. This generic type of device system includes serial, manual, automated, and semi-automated dilutors, pipettors, dispensers, and pipetting stations.

• Plasma Coagulation Control (FDA Code: GGN / 864.5425)

• Platelet Aggregation Reagents (FDA Code: GHR / 864.5700) An automated platelet aggregation system is a device used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet-rich plasma.

• POC Coagulation Analyzers (PT and INR)

• Point-of-care (POC) Coagulation Analyzers

• Ponceau Stain (FDA Code: HZO / 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.

• Porphyrins Fluorometric Measurement (FDA Code: JKJ / 862.1595) A porphyrins test system is a device intended to measure porphyrins (compounds formed during the biosynthesis of heme, a constituent of hemoglobin, and related compounds) in urine and feces. Measurements obtained by this device are used in the diagnosis and treatment of lead poisoning, porphyrias (primarily inherited diseases associated with disturbed porphyrin metabolism), and other diseases characterized by alterations in the heme pathway.

• Prealbumin Antiserum (FDA Code: JZJ / 866.5060) A prealbumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the prealbumin (a plasma protein) in serum and other body fluids. Measurement of prealbumin levels in serum may aid in the assessment of the patient's nutritional status.

• Programmable Multi-Channel Chemistry Analyzer

• Programmable Single Channel Chemistry Analyzer

• Protein Fractionation Electrophoretic Test (FDA Code: CEF / 862.1630) A protein (fractionation) test system is a device intended to measure protein fractions in blood, urine, cerebrospinal fluid, and other body fluids. Protein fractionations are used as an aid in recognizing abnormal proteins in body fluids and genetic variants of proteins produced in diseases with tissue destruction.

• Prothrombin Time Test (FDA Code: GJS / 864.7750) A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).

• Qualitative and Quantitative Factor Deficiency Test (FDA Code: GGP / 864.7290) A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).

• Racked Non-Sterile Non-Barrier Multi-Channel Pipette Tips

• Racked Non-Sterile Non-Barrier Pipette Tips

• Radial Immunodiffusion Plates and Equipment (FDA Code: JZQ / 866.4800) A radial immunodiffusion plate for clinical use is a device that consists of a plastic plate to which agar gel containing antiserum is added. In radial immunodiffusion, antigens migrate through gel which originally contains specific antibodies. As the reagents come in contact with each other, they combine to form a precipitate that is trapped in the gel matrix and immobilized.