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Address: 13665 Dulles Technology Drive, Herndon, Virginia 20171-4603, USA
www.focusdx.com |
Phone: +1-(703)-480-2500
FDA Registration: 2023365
Products: Alcohol (Ethanol) Saliva Test Kits, Allergy skin Test Kit, Allergy Blood Test Kit, Allergy Patch Test Kit, Alanine Aminotransferase Testing Kit, 11-keto Testosterone EIA Kit, ...
Focus Diagnostics, Inc. develops & markets quality services for rare, unusual and emerging infectious & immunologic diseases. We are an ISO 13485 certified company. We offer products like HerpeSelectr
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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: 3661 Horseblock Road, Medford, New York 11763, USA
www.chembio.com |
Send Inquiry |
Phone: +1-(631)-924-1135
FDA Registration: 2431980
Products: Chlamydia trachomatis IgA ELISA Kit, Chlamydia trachomatis IgG ELISA Kit, Chlamydia Trachomatis (FDA Code:
MGM), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code:
JJX), Campylobacter Pylori (FDA Code:
LYR), Borrelia Serological Reagent (FDA Code:
LSR), ...
Chembio Diagnostic Systems, Inc. develops and manufactures point-of-care (POC) diagnostic tests and technology for infectious diseases. Our products serve diverse markets that are global. We also expo
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FDA Code / Regulation: GQC / 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.
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 866.9.