(82 days)
The QUANTA Lite TM Rubeola (Measles) IgG ELISA System is designed for the qualitative determination of IgG antibodies to rubeola (measles) in human serum from adult, neonate, and immunocompromised patients. The test system is intended to be used to evaluate serologic evidence of previous infection with rubeola (measles) and as an aid in the diagnosis of rubeola (measles) infection.
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§ 866.3520 Rubeola (measles) virus serological reagents.
(a)
Identification. 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.(b)
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.