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Bion Enterprises Ltd.

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Contact: Melinda Aschner - QC Manager
Web: http://www.bionenterprises.com
E-Mail:
Address: 455 State St., Ste. 100, Des Plaines, Illinois 60016-2204, USA
Phone: +1-(847)-544-5044 | Fax: +1-(847)-544-5051 | Map/Directions >>
 
 

Profile: Bion Enterprises Ltd. is a manufacturer of in-vitro diagnostic products for immunology, virology and microbiology. The ANA (HEp-2) antigen substrate slides may be used as the antigenic substrate in indirect fluorescent antibody assays for the qualitative and/or semi-quantitative determination of antinuclear antibodies in human serum. ANA (HEp-2) antigen substrate slides are intended for use as an aid in the diagnosis of certain autoimmune diseases. IFA antigen substrate slides are intended for use as the antigenic component in indirect immunoassay systems for the qualitative and/or semi-quantitative detection of specific antibodies in human serum. These antigen substrates can be used in immunofluorescence assays, immunoperoxidase staining techniques and in DNA probe methodologies. A special hydrophobic mask prevents intermixing of specimens.

The company was founded in 1978, has revenues of USD 1-5 Million, has ~30 employees and is ISO certified.

FDA Registration Number: 1419968

25 Products/Services (Click for related suppliers)  
• 2 Herpesvirus Hominis 1 Cf Antisera (FDA Code: GQO / 866.3305)
• Antinuclear Antibody, Indirect Immunofluorescen (FDA Code: DHN / 866.5100)
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).
• B 1-6 Coxsackievirus A 1-24 Neutralization Antiserum (FDA Code: GNN / 866.3145)
Coxsackievirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to coxsackievirus in serum. Additionally, some of these reagents consist of coxsackievirus antisera conjugated with a fluorescent dye that are used to identify coxsackievirus from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of coxsackievirus infections and provides epidemiological information on diseases caused by these viruses. Coxsackieviruses produce a variety of infections, including common colds, meningitis (inflammation of brain and spinal cord membranes), herpangina (brief fever accompanied by ulcerated lesions of the throat), and myopericarditis (inflammation of heart tissue).
• Borrelia Serological Reagent (FDA Code: LSR / 866.3830)
• Chlamydia Spp Fluorescent Antisera (FDA Code: LKI / 866.3120)
Chlamydia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to chlamydia in serum. Additionally, some of these reagents consist of chlamydia antisera conjugated with a fluorescent dye used to identify chlamydia directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusChlamydia and provides epidemiological information on these diseases. Chlamydia are the causative agents of psittacosis (a form of pneumonia), lymphogranuloma venereum (a venereal disease), and trachoma (a chronic disease of the eye and eyelid).
• Cytomegalovirus CF Antigen (FDA Code: GQH / 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.
• Echovirus 1-34 Neutralization Antisera (FDA Code: GNI / 866.3205)
Echovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to echovirus in serum. Additionally, some of these reagents consist of echovirus antisera conjugated with a fluorescent dye used to identify echoviruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of echovirus infections and provides epidemiological information on diseases caused by these viruses. Echoviruses cause illnesses such as meningitis (inflammation of the brain and spinal cord membranes), febrile illnesses (accompanied by fever) with or without rash, and the common cold.
• Epstein-Barr Virus Fluorescent Antiserum (FDA Code: JRY / 866.3235)
Epstein-Barr virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Epstein-Barr virus in serum. The identification aids in the diagnosis of Epstein-Barr virus infections and provides epidemiological information on diseases caused by these viruses. Epstein-Barr viruses are thought to cause infectious mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw in African children and young adults) and postnasal carcinoma (cancer).
• Epstein-Barr Virus IF Antibody IGM (FDA Code: LJN / 866.3235)
• Epstein-Barr Virus Nuclear Antigen Test (FDA Code: LLM / 866.3235)
• Fluorescent Adenovirus 1-33 Antisera (FDA Code: GNY / 866.3020)
Adenovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to adenovirus in serum. Additionally, some of these reagents consist of adenovirus antisera conjugated with a fluorescent dye and are used to identify adenoviruses directly from clinical specimens. The identification aids in the diagnosis of disease caused by adenoviruses and provides epidemiological information on these diseases. Adenovirus infections may cause pharyngitis (inflammation of the throat), acute respiratory diseases, and certain external diseases of the eye (e.g., conjunctivitis).
• General Purpose Reagent (FDA Code: LDT)
• IFA Antibody Antigen Respiratory Syncytial Virus (FDA Code: LKT / 866.3480)
Respiratory syncytial virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to respiratory syncytial virus in serum. Additionally, some of these reagents consist of respiratory syncytial virus antisera conjugated with a fluorescent dye (immunofluorescent reagents) and used to identify respiratory syncytial viruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of respiratory syncytial virus infections and provides epidemiological information on diseases caused by these viruses. Respiratory syncytial viruses cause a number of respiratory tract infections, including the common cold, pharyngitis, and infantile bronchopneumonia.
• Influenza Virus Antisera (FDA Code: GNS / 866.3330)
Influenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to influenza in serum. The identification aids in the diagnosis of influenza (flu) and provides epidemiological information on influenza. Influenza is an acute respiratory tract disease, which is often epidemic.
• Mounting Media (FDA Code: LEB / 864.4010)
• Mumps Virus Fluorescent Antiserum Test (FDA Code: GRA / 866.3380)
Mumps virus serological reagents consist of antigens and antisera used in serological tests to identify antibodies to mumps virus in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used in serological tests to identify mumps viruses from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of mumps and provides epidemiological information on mumps. Mumps is an acute contagious disease, particularly in children, characterized by an enlargement of one or both of the parotid glands (glands situated near the ear), although other organs may also be involved.
• Mycoplasma Spp. DNA-Reagents (FDA Code: LQG / 866.3375)
• Parainfluenza Virus 1-4 HAI Antisera (FDA Code: GQQ / 866.3400)
Parainfluenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to parainfluenza virus in serum. The identification aids in the diagnosis of parainfluenza virus infections and provides epidemiological information on diseases caused by these viruses. Parainfluenza viruses cause a variety of respiratory illnesses ranging from the common cold to pneumonia.
• Parainfluenza Virus 1-4 Neutralization Antisera (FDA Code: GQP / 866.3400)
• pH Buffer (FDA Code: JCC / 864.4010)
• 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.
• Reagents
• Rubeola Fluorescent Antiserum (FDA Code: GRE / 866.3520)
Rubeola (measles) virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubeola virus in serum. The identification aids in the diagnosis of measles and provides epidemiological information on the disease. Measles is an acute, highly infectious disease of the respiratory and reticuloendothelial tissues, particularly in children, characterized by a confluent and blotchy rash.
• Rubeola HAI Antiserum (FDA Code: GRG / 866.3520)
• Varicella-Zoster CF Antigen (FDA Code: GQW / 866.3900)
Varicella-zoster virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to varicella-zoster in serum. The identification aids in the diagnosis of diseases caused by varicella-zoster viruses and provides epidemiological information on these diseases. Varicella (chicken pox) is a mild, highly infectious disease, chiefly of children. Zoster (shingles) is the recurrent form of the disease, occurring in adults who were previously infected with varicella-zoster viruses. Zoster is the response (characterized by a rash) of the partially immune host to a reactivation of varicella viruses present in latent form in the patient's body.

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