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FDA Registration Number: 1050190

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• 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 CF Antigen (FDA Code: GOH / 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.

• Poliovirus 1-3 CF Antisera (FDA Code: GOG / 866.3405)

• Poliovirus 1-3 Neutralization Antisera (FDA Code: GOF / 866.3405)

• Positive and Negative Febrile Antigen Control Serum (FDA Code: GSN / 866.3085)

• Pseudomonas Pseudomallei Fluorescent Antisera (FDA Code: GSR / 866.3415)

• Q Fever CF Antigen Test (FDA Code: GPS / 866.3500) Rickettsia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rickettsia in serum. Additionally, some of these reagents consist of rickettsial antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify rickettsia directly from clinical specimens. The identification aids in the diagnosis of diseases caused by virus-like bacteria belonging to the genusRickettsiae and provides epidemiological information on these diseases. Rickettsia are generally transmitted by arthropods (e.g., ticks and mosquitoes) and produce infections in humans characterized by rash and fever (e.g., typhus fever, spotted fever, Q fever, and trench fever).

• Q Fever CF Antiserum Test (FDA Code: GPR / 866.3500)

• Reovirus 1-3 Ha (Including Ha Control) Antigens (FDA Code: GQA / 866.3470) Reovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to reovirus in serum. The identification aids in the diagnosis of reovirus infections and provides epidemiological information on diseases caused by these viruses. Reoviruses are thought to cause only mild respiratory and gastrointestinal illnesses.

• Reovirus 1-3 Hai Antisera (FDA Code: GPY / 866.3470)

• 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.

• Respiratory Syncytial Virus Neutralization Antiserum Test (FDA Code: GQF / 866.3480)

• Rubeola CF Antigen (FDA Code: GRJ / 866.3520) Rubeola (measles) virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubeola virus in serum. The identification aids in the diagnosis of measles and provides epidemiological information on the disease. Measles is an acute, highly infectious disease of the respiratory and reticuloendothelial tissues, particularly in children, characterized by a confluent and blotchy rash.

• Rubeola Cf Antiserum (FDA Code: GRF / 866.3520)

• Rubeola Ha (Including Ha Control) Antigen (FDA Code: GRH / 866.3520)

• Rubeola HAI Antiserum (FDA Code: GRG / 866.3520)

• Rubeola Neutralization Antiserum (FDA Code: GRI / 866.3520)

• Salmonella Spp Antiserum (FDA Code: GRM / 866.3550)

• Salmonella SPP Fluorescent Antisera (FDA Code: GOO / 866.3550)

• Shigella Spp. All Globulins Fluorescent Antisera (FDA Code: GTD / 866.3660)

• Sporothrix Schenekii Fluorescent Antisera (FDA Code: GMA / 866.3680)

• Spotted Fever Group Cf Antigen (FDA Code: GPQ / 866.3500)

• Staphylococcal Typing Phages (FDA Code: GTL / 866.2050) A staphylococcal typing bacteriophage is a device consisting of a bacterial virus intended for medical purposes to identify pathogenic staphylococcal bacteria through use of the bacteria's susceptibility to destruction by the virus. Test results are used principally for the collection of epidemiological information.

• Streptococcus Pneumoniae Antisera (FDA Code: GWC / 866.3740)

• Streptococcus Pneumoniae Fluorescent Antiserum (FDA Code: GWB / 866.3740)

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

• Streptococcus Spp Groups Fluorescent Antiserum (FDA Code: GTX / 866.3740)

• Typhus Fever Antiserum Test (FDA Code: GPN / 866.3500)

• Typhus Fever Group CF Antigen Test (FDA Code: GPO / 866.3500)

• Vibrio Cholerae Antiserum (FDA Code: GSQ / 866.3930)

• Yeast Identification Kit (FDA Code: JXB / 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.