Profile: Biodesign International markets antigen and antibodies. We concentrate on diagnostic, pharmaceutical and life science researches. We are certified with ISO 9001:2000 standard. We deal in monoclonal & polyclonal antibodies, purified antigens and assay development reagents. We produce drug antibodies, lipoproteins, enzymes and animal sera.

The company was founded in 1983, has ~20 employees and is ISO 9001 certified. NASDAQ:VIVO (SEC Filings)

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• Adenovirus 1-33 CF Antigen (FDA Code: GOD / 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).

• Analyte Specific Reagents, Asr Reagents (FDA Code: MVU / 864.4020) Analyte specific reagents (ASR's) are antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens. ASR's that otherwise fall within this definition are not within the scope of subpart E of this part when they are sold to:

• Aspergillus Spp CF Antigen (FDA Code: JWT / 866.3040)

• Aspergillus Spp. Positive Control Antiserum (FDA Code: KFG / 866.3040)

• Autoimmune Test Kits

• Borrelia Serological Reagent (FDA Code: LSR / 866.3830)

• Campylobacter Pylori (FDA Code: LYR / 866.3110)

• Campylobacter Spp. (FDA Code: LQP / 866.3110)

• Cancer Test Kits

• 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).

• Clostridium Difficile Toxin Reagent (FDA Code: LLH / 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.

• Coccidioides Immitis CF and ID Antigen (FDA Code: GMI / 866.3135)

• Coccidioides Immitis Enzyme Linked Immunoabsorbent Assay (FDA Code: MIY / 866.3135)

• Coccidioides Immitis Latex Agglutination Antigen Test (FDA Code: GMG / 866.3135)

• Coccidioides Immitis Positive Control Antiserum Test (FDA Code: GMH / 866.3135)

• Cryptococcus Antigen Enzyme Linked Immunoabsorbent Assay Antigen (FDA Code: MDU / 866.3165)

• Cytomegalovirus CF Antiserum Test (FDA Code: GQI / 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.

• Epstein-Barr Virus (FDA Code: LSE / 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 Fluorescent Antiserum (FDA Code: JRY / 866.3235)

• Epstein-Barr Virus IF Antibody IGM (FDA Code: LJN / 866.3235)

• Epstein-Barr Virus Nuclear Antigen Test (FDA Code: LLM / 866.3235)

• Escherichia Coli Antigens (FDA Code: GMZ / 866.3255)

• Escherichia Coli Antisera (FDA Code: GNA / 866.3255)

• Formaldehyde (FDA Code: IGG / 864.4010)

• Formalin Containing Fixative (FDA Code: LDY / 864.4010)

• Giardia Spp. (FDA Code: MHI / 866.3220)

• Histology Test Kits

• Histoplasma Capsulatum Antigen (FDA Code: GMJ / 866.3320)

• Histoplasma Capsulatum Positive Control Antiserum Test (FDA Code: GMK / 866.3320)

• IgG Control (FDA Code: DEW / 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.

• Immunoassay Reagents & Test Kits

• Infectious Mononucleosis Test System (FDA Code: KTN / 866.5640) An infectious mononucleosis immunological test system is a device that consists of the reagents used to measure by immunochemical techniques heterophile antibodies frequently associated with infectious mononucleosis in serum, plasma, and other body fluids. Measurements of these antibodies aid in the diagnosis of infectious mononucleosis.

• Influenza Virus CF Antigen (FDA Code: GNX / 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.

• Latex Agglutination Test for Cryptococcus neoformans (FDA Code: GMD / 866.3165)

• Mallory's Trichrome Stain (FDA Code: HYW / 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.

• Mercuric Chloride Formulations for Tissue (FDA Code: IFQ / 864.4010)

• Metallic Containing Fixative (FDA Code: LDX / 864.4010)

• Microbiological Stain (FDA Code: JTS / 864.1850)

• Molecular Biology, Reagents

• Mycoplasma Spp Enzyme Linked Immunoabsorbent Assay (FDA Code: LJZ / 866.3375)

• Non-Propagating Transport Culture Media (FDA Code: JSM / 866.2390) A transport culture medium is a device that consists of a semisolid, usually non-nutrient, medium that maintains the viability of suspected pathogens contained in patient specimens while in transit from the specimen collection area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.

• Parasite Concentration Analyzer (FDA Code: LKS / 866.2900) A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.

• Pneumocystis Carinii (FDA Code: LYF / 866.3780)

• Poliovirus 1-3 CF Antisera (FDA Code: GOG / 866.3405) Poliovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to poliovirus in serum. Additionally, some of these reagents consist of poliovirus antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify polioviruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of poliomyelitis (polio) and provides epidemiological information on this disease. Poliomyelitis is an acute infectious disease which in its serious form affects the central nervous system resulting in atrophy (wasting away) of groups of muscles, ending in contraction and permanent deformity.

• 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.

• Respiratory Syncytial CF Antigen (FDA Code: GQG / 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.

• Rotavirus Enzyme Linked Immunoabsorbent Assay (FDA Code: LIQ / 866.3405)

• Staphylococcus Aureus Somatic Antigen Test (FDA Code: LHT / 866.3700)

• Sterile Specimen Container (FDA Code: FMH / 864.3250) A specimen transport and storage container, which may be empty or prefilled, is a device intended to contain biological specimens, body waste, or body exudate during storage and transport in order that the matter contained therein can be destroyed or used effectively for diagnostic examination. If prefilled, the device contains a fixative solution or other general purpose reagent to preserve the condition of a biological specimen added to the container. This section does not apply to specimen transport and storage containers that are intended for use as part of an over-the-counter test sample collection system for drugs of abuse testing.

• Sterile Specimen Mailer and Storage Container (FDA Code: KDT / 864.3250)