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25 Products/Services (Click for related suppliers)
|• (FDA Code: DCF / 866.5040)|
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.
|• (FDA Code: KSZ / 864.9175)|
An automated blood grouping and antibody test system is a device used to group erythrocytes (red blood cells) and to detect antibodies to blood group antigens.
|• (FDA Code: KSS / 864.9050)|
Blood bank supplies are general purpose devices intended for in vitro use in blood banking. This generic type of device includes products such as blood bank pipettes, blood grouping slides, blood typing tubes, blood typing racks, and cold packs for antisera reagents. The device does not include articles that are licensed by the Center for Biologics Evaluation and Research of the Food and Drug Administration.
|• (FDA Code: GIF / 864.8200)|
A blood cell diluent is a device used to dilute blood for further testing, such as blood cell counting.
|• (FDA Code: KSX / 864.9160)|
Blood group substances of nonhuman origin for in vitro diagnostic use are materials, such as blood group specific substances prepared from nonhuman sources (e.g., pigs, cows, and horses) used to detect, identify, or neutralize antibodies to various human blood group antigens. This generic type of device does not include materials that are licensed by the Center for Biologics Evaluation and Research of the Food and Drug Administration.
|• (FDA Code: LJO / 866.3175)|
Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to cytomegalovirus in serum. The identification aids in the diagnosis of diseases caused by cytomegaloviruses (principally cytomegalic inclusion disease) and provides epidemiological information on these diseases. Cytomegalic inclusion disease is a generalized infection of infants and is caused by intrauterine or early postnatal infection with the virus. The disease may cause severe congenital abnormalities, such as microcephaly (abnormal smallness of the head), motor disability, and mental retardation. Cytomegalovirus infection has also been associated with acquired hemolytic anemia, acute and chronic hepatitis, and an infectious mononucleosis-like syndrome.
|• (FDA Code: KSW / 864.9145)|
A processing system for frozen blood is a device used to glycerolize red blood cells prior to freezing to minimize hemolysis (disruption of the red cell membrane accompanied by the release of hemoglobin) due to freezing and thawing of red blood cells and to deglycerolize and wash thawed cells for subsequent reinfusion.
|• (FDA Code: KSG / 864.9600)|
Potentiating media for in vitro diagnostic use are media, such as bovine albumin, that are used to suspend red cells and to enhance cell reactions for antigen-antibody testing.
|• (FDA Code: KSI / 864.9550)|
Lectins and protectins are proteins derived from plants and lower animals that cause cell agglutination in the presence of certain antigens. These substances are used to detect blood group antigens for in vitro diagnostic purposes.
|• (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.
|• (FDA Code: JCC / 864.4010)|
|• (FDA Code: MYP)|
|• (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.
|• (FDA Code: DDF / 866.5735)|
A prothrombin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the prothrombin (clotting factor II) in serum. Measurements of the amount of antigenically competent (ability to react with protein antibodies) prothrombin aid in the diagnosis of blood-clotting disorders.
|• (FDA Code: KSF / 864.9650)|
A quality control kit for blood banking reagents is a device that consists of sera, cells, buffers, and antibodies used to determine the specificity, potency, and reactivity of the cells and reagents used for blood banking.
|• (FDA Code: LSQ / 866.3500)|
Rickettsia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rickettsia in serum. Additionally, some of these reagents consist of rickettsial antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify rickettsia directly from clinical specimens. The identification aids in the diagnosis of diseases caused by virus-like bacteria belonging to the genusRickettsiae and provides epidemiological information on these diseases. Rickettsia are generally transmitted by arthropods (e.g., ticks and mosquitoes) and produce infections in humans characterized by rash and fever (e.g., typhus fever, spotted fever, Q fever, and trench fever).
|• (FDA Code: KSK / 864.9400)|
A stabilized enzyme solution is a reagent intended for medical purposes that is used to enhance the reactivity of red blood cells with certain antibodies, including antibodies that are not detectable by other techniques. These enzyme solutions include papain, bromelin, ficin, and trypsin.
|• (FDA Code: LIM / 864.7455)|
A fetal hemoglobin assay is a device that is used to determine the presence and distribution of fetal hemoglobin (hemoglobin F) in red cells or to measure the amount of fetal hemoglobin present. The assay may be used to detect fetal red cells in the maternal circulation or to detect the elevated levels of fetal hemoglobin exhibited in cases of hemoglobin abnormalities such as thalassemia (a hereditary hemolytic anemia characterized by a decreased synthesis of one or more types of hemoglobin polypeptide chains). The hemoglobin determination may be made by methods such as electrophoresis, alkali denaturation, column chromatography, or radial immunodiffusion.
|• (FDA Code: MYR / 866.3830)|