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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• Respiratory Syncytial Virus (RSV) Test Kits

• Respiratory Syncytial Virus - Elisa (FDA Code: MCE / 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) 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.

• Rotavirus Test Kits

• Rotavirus Test, Gastroenteritis

• Specimen Collection Device (FDA Code: LIO / 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.

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

• Streptococcus Spp Antigen (FDA Code: GTY / 866.3740)

• Streptococcus Spp Antiserum (FDA Code: GTZ / 866.3740)

• Swabs, Respiratory Syncytial Virus (RSV) Test Kits

• Urine Screening Kit (FDA Code: JXA / 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.

• Water Soluble Mounting Media (FDA Code: KEQ / 864.4010)

• Water-microbiology kit