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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).

• Adenovirus 1-33 CF Antisera (FDA Code: GOA / 866.3020)

• Adenovirus 1-33 Neutralization Antisera (FDA Code: GNZ / 866.3020)

• Arizona Spp Antiserum (FDA Code: GTE / 866.3035)

• B 1-6 Coxsackievirus A 1-24 CF Antisera (FDA Code: GNO / 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).

• B 1-6 Coxsackievirus A 1-24 Neutralization Antiserum (FDA Code: GNN / 866.3145)

• B. Dermatitidis Antigen (FDA Code: JWW / 866.3060)

• Blastomyces Dermatitidis Positive Control Antiserum Test (FDA Code: KFH / 866.3060)

• Brucella Spp Agglutination Antigen (FDA Code: GSO / 866.3085)

• C B Influenza Virus A Ha (Including Ha Control) Antigens (FDA Code: GNT / 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.

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

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

• Compound S (11-Deoxycortisol) Radioimmunoassay (FDA Code: JKB / 862.1185) A compound S (11-dioxycortisol) test system is a device intended to measure the level of compound S (11-dioxycortisol) in plasma. Compound S is a steroid intermediate in the biosynthesis of the adrenal hormone cortisol. Measurements of compound S are used in the diagnosis and treatment of certain adrenal and pituitary gland disorders resulting in clinical symptoms of masculinization and hypertension.

• Coxsackievirus A 1-24 CF Antigen (FDA Code: GNG / 866.3145)

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

• Cryptococcus Neoformans Positive Control Antigen Test (FDA Code: JWK / 866.3165)

• Echovirus 1-34 CF Antigen (FDA Code: GNL / 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.

• Echovirus 1-34 CF Antisera (FDA Code: GNK / 866.3205)

• Echovirus 1-34 Neutralization Antisera (FDA Code: GNI / 866.3205)

• Equine Encephalitis CF Antigen (FDA Code: GQD / 866.3240) Equine encephalomyelitis virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antobodies to equine encephalomyelitis virus in serum. The identification aids in the diagnosis of diseases caused by equine encephalomyelitis viruses and provides epidemiological information on these viruses. Equine encephalomyelitis viruses are transmitted to humans by the bite of insects, such as mosquitos and ticks, and may cause encephalitis (inflammation of the brain), rash, acute arthritis, or hepatitis.

• Equine Encephalitis Virus CF Antisera (FDA Code: GQC / 866.3240)

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

• Escherichia Coli Fluorescent Antisera (FDA Code: GMY / 866.3255)

• Fluorescent B. Pertussis Antisera (FDA Code: GOZ / 866.3065)

• Francisella Tularensis Antiserum Test (FDA Code: GSK / 866.3280)

• Francisella Tularensis Fluorescent Antiserum Test (FDA Code: GSJ / 866.3280)

• Francisella Tularensis Slide and Tube Antigen Test (FDA Code: GSL / 866.3280)

• Haemophilus Influenza Antiserum (FDA Code: GRP / 866.3300)

• Healthcare Service

• Hemophilus Spp Fluorescent Antisera (FDA Code: GRO / 866.3300)

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

• Histoplasma Capsulatum Fluorescent Antisera (FDA Code: GML / 866.3320)

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

• Influenza Virus (A, B, C) Antisera (FDA Code: GNW / 866.3330)

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

• Influenza Virus CF Antigen (FDA Code: GNX / 866.3330)

• Klebsiella Spp Antiserum (FDA Code: GTC / 866.3340)

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

• Leptospira Spp Antisera (FDA Code: GRX / 866.3350)

• Mumps Virus Cf Antiserum (FDA Code: GRB / 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.

• Mumps Virus Ha (Including Ha Control) Antigen (FDA Code: GQY / 866.3380)

• Mumps Virus Hai Antiserum (FDA Code: GRD / 866.3380)

• Mumps Virus, CF Antigen (FDA Code: GRC / 866.3380)

• Mycoplasma Spp Antiserum (FDA Code: GSA / 866.3375)

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

• Neuramininase (FDA Code: IBE / 864.4400) Enzyme preparations are products that are used in the histopathology laboratory for the following purposes:

• Parainfluenza Virus 1-4 CF Antisera (FDA Code: GQT / 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 Ha (Including Ha Control) Antigens (FDA Code: GQR / 866.3400)

• Parainfluenza Virus 1-4 HAI Antisera (FDA Code: GQQ / 866.3400)

• Parainfluenza Virus 1-4 Neutralization Antisera (FDA Code: GQP / 866.3400)