Diagnostic Hybrids

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Contact: David R. Scholl, Ph.D. - President & CEO
Web: http://www.dhiusa.com
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Address: 1055 East State St., Suite 100, Athens, Ohio 45701, USA
Phone: +1-(740)-589-3300, 800-344-5847 | Fax: +1-(740)-592-9820 | Map/Directions >>

Profile: Diagnostic Hybrids innovates, develops, manufactures and markets cellular & molecular diagnostic kits for various applications in detecting a wide range of respiratory diseases, herpes infections, thyroid function, & other high value markers of disease. Our products provide an accurate, rapid and cost-effective diagnosis. Our new flocked swab and universal transport medium (UTM) combination optimizes both the collection & transport of critical virology specimens. The flocked swabs decrease rejected samples by absorbing more collected cells. They increase assay sensitivity by releasing more sample cells into the transport medium. We are committed to providing clinicians with the appropriate educational materials needed to order and use viral respiratory tests & herpes disease tests.

The company was founded in 1983 and is ISO 13485 certified.

FDA Registration Number: 1528450

33 Products/Services (Click for related suppliers)

• 2 Herpesvirus Hominis 1 CF Antigen (FDA Code: GQN / 866.3305)

• 2 Herpesvirus Hominis 1 Fluorescent Antisera (FDA Code: GQL / 866.3305)

• 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:

• B 1-6 Coxsackievirus A 1-24 Fluorescent Antisera Test (FDA Code: GNM / 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).

• Balanced Salt Solutions (FDA Code: KIP / 864.2875)

A balanced salt solution or formulation is a defined mixture of salts and glucose in a simple medium. This device is included as a necessary component of most cell culture systems. This media component controls for pH, osmotic pressure, energy source, and inorganic ions.

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

• Cultured Animal and Human Cells (FDA Code: KIR / 864.2280)

Cultured animal and human cells are in vitro cultivated cell lines from the tissue of humans or other animals which are used in various diagnostic procedures, particularly diagnostic virology and cytogenetic studies.

• 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 Kits

• Echovirus 1-34 Fluorescent Antisera Test (FDA Code: GRK / 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.

• Endocrine/Thyroid Testing

• Enterovirus Testing Solutions

• Flocked Swabs

• 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).

• Heating Block (FDA Code: JRG / 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.

• Human Metapneumovirus Fluorescent Antisera (FDA Code: OMG / 866.3980)

• 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 A&B Kit

• Influenza A, B Test Kits

• Influenza Virus (A, B, C) Antisera (FDA Code: GNW / 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.

• Influenza Virus Antisera (FDA Code: GNS / 866.3330)

• Mounting Media (FDA Code: LEB / 864.4010)

• Parainfluenza Virus CF Antigen (FDA Code: GQS / 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.

• Poliovirus 1-3 Fluorescent Antisera Test (FDA Code: GOE / 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.

• 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.

• Respiratory Screening Kits

• Respiratory Syncytial CF Antigen (FDA Code: GQG / 866.3480)

• Respiratory Virus ID Kits

• Sterile Absorbent Tipped Applicator (FDA Code: KXG / 880.6025)

An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic stick. The device is used to apply medications to, or to take specimens from, a patient.

• Swabs

• Synthetic Cell and Tissue Culture Media and Components (FDA Code: KIT / 864.2220)

Synthetic cell and tissue culture media and components are substances that are composed entirely of defined components (e.g., amino acids, vitamins, inorganic salts) that are essential for the survival and development of cell lines of humans and other animals. This does not include tissue culture media for human ex vivo tissue and cell culture processing applications as described in 876.5885 of this chapter.

• Thyroid Autoantibody Test System (FDA Code: JZO / 866.5870)

A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.

• 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.