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Address: 1600 Clifton Rd., Atlanta, Georgia 30333, USA
www.cdc.gov |
Send Inquiry |
Phone: +1-(888)-232-6348
FDA Registration: 1050190 Employee Count: ~180
Products: Healthcare Service, Arizona Spp Antiserum (FDA Code:
GTE), Fluorescent B. Pertussis Antisera (FDA Code:
GOZ), Brucella Spp Agglutination Antigen (FDA Code:
GSO), Escherichia Coli Antisera (FDA Code:
GNA), Positive and Negative Febrile Antigen Control Serum (FDA Code:
GSN), ...
Centers for Disease Control and Prevention is an online source for health information.
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Address: 455 State St., Ste. 100, Des Plaines, Illinois 60016-2204, USA
www.bionenterprises.com |
Send Inquiry |
Phone: +1-(847)-544-5044
FDA Registration: 1419968 Year Established: 1978
Annual Revenues: USD 1-5 Million
Employee Count: ~30
Quality: ISO Certified
Products: Reagents, B 1-6 Coxsackievirus A 1-24 Neutralization Antiserum (FDA Code:
GNN), Echovirus 1-34 Neutralization Antisera (FDA Code:
GNI), Mycoplasma Spp. DNA-Reagents (FDA Code:
LQG), Parainfluenza Virus 1-4 Neutralization Antisera (FDA Code:
GQP), General Purpose Reagent (FDA Code:
LDT), ...
Bion Enterprises Ltd. is a manufacturer of in-vitro diagnostic products for immunology, virology and microbiology. The ANA (HEp-2) antigen substrate slides may be used as the antigenic substrate in in
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Address: Via Castagnetta 7, Pomezia 00040, Italy
Phone: +39-(6)-9195735
Products: C-Reactive Protein Test System (FDA Code:
DCN), Rheumatoid Factor Test System (FDA Code:
DHR), 2 Herpesvirus Hominis 1 CF Antigen (FDA Code:
GQN), 2 Herpesvirus Hominis 1 Cf Antisera (FDA Code:
GQO), Adenovirus 1-33 CF Antigen (FDA Code:
GOD), Adenovirus 1-33 CF Antisera (FDA Code:
GOA), ...
Alfa Biotech Spa specializes in offering vaccines, blood products and diagnostic products for laboratory & medical use.
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FDA Code / Regulation: GNI / 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.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 866.9.