Profile: Meridian Bioscience, Inc. is a fully integrated life science company that manufactures, markets and distributes a broad range of diagnostic test kits. Our product immunocard stat campy is an immunochromatographic rapid test for the qualitative detection of specific campylobacter antigens in human stool. Our product premier campy is an enzyme immunoassay for the detection of campylobacter antigens. ImmunoCard STAT!® HpSA® is a rapid one-step EIA for the detection of Helicobacter pylori antigens in human stool. Premier™ Adenoclone® is a qualitative ELISA for the detection of human adenoviruses.

The company was founded in 1977, has revenues of USD 100-500 Million, has ~250 employees.

FDA Registration Number: 1524213

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• Anti-acetylcholine Receptor Alpha Monoclonal Antibody

• Bacterial Diagnostic Test

• Campylobacter Pylori (FDA Code: LYR / 866.3110)

• Chemistry Analyzers

• Chlamydia Group Enzyme Linked Immunoabsorbent Assay (FDA Code: LJC / 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).

• Chlamydia Spp Fluorescent Antisera (FDA Code: LKI / 866.3120)

• Chlamydia Trachomatis Fluorescent Antiserum (FDA Code: LJP / 866.3120)

• Clinical Immunochemistry Analyzers

• Clostridium difficile Test Kits

• 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)

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

• Cryptococcus Neoformans Fluorescent Antisera (FDA Code: GME / 866.3165)

• Cryptosporidium Spp. (FDA Code: MHJ / 866.3220)

• Cytomegalovirus Conjugated Fluorescent Antisera Test (FDA Code: LIN / 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.

• Diagnostic Aids

• ELISA Chemistry Analyzer

• Enterobacteriaceae Identification Kit (FDA Code: JSS / 866.2660)

• Enzyme Immunoassay Chemistry Analyzer

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

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

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

• Formalin/Sodium Acetate Solution (FDA Code: IGB / 864.4010)

• General Diagnostic Supplies

• General Diagnostics

• General Medical Supplies

• Helicobacter pylori Antibody Kits

• Herpes Simplex Virus Enzyme Linked Immunoabsorbent Assay (FDA Code: LGC / 866.3305)

• 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.

• Immuno Chemistry Analyzers

• Immunoassay Equipment, Immunochemistry Analyzers

• Immunodiffusion Method, Immunoglobulins G, A, M (FDA Code: CGM / 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.

• Indirect Immunofluorescent Multiple Auto Antibody (FDA Code: DBL / 866.5660) 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).

• Infectious Disease Exams

• Infectious Disease Testing, Rotavirus 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.

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

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

• Microbiological Stain (FDA Code: JTS / 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.

• Microbiology Kit

• Monoclonal Antibody Test

• Mononucleosis Antibody (MONO) Test Kits

• Mycoplasma Spp CF Antigen (FDA Code: GSB / 866.3375)

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

• Neutral Buffered Formalin (FDA Code: IFP / 864.4010)

• 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)

• 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.