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Address: 12076 Santa Fe Drive, P.O. Box 14428, Lenexa, Kansas 66215, USA
www.remelinc.com |
Send Inquiry |
Phone: +1-(913)-888-0939
FDA Registration: 1031428 Year Established: 1973
Employee Count: ~20
Products: Pregnancy Kits, Cotton Swabs, Home pregnancy test kits, Hcg, Early Pregnancy Testing Kit, Sensitive Pregnancy Tests, Diagnostic Test Kits For Pregnancy, ...
Remel offers a wide range of microbiology products that are used in the clinical, industrial, research and academic laboratories. Our products help diagnose infection quickly and accurately, providing
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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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FDA Code / Regulation: GRD / 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.
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.