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e-CFR data is current as of July 7, 2020

Title 21Chapter ISubchapter HPart 866Subpart D → §866.3360


Title 21: Food and Drugs
PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart D—Serological Reagents


§866.3360   Lymphocytic choriomeningitis virus serological reagents.

(a) Identification. Lymphocytic choriomeningitis virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to lymphocytic choriomeningitis virus in serum. The identification aids in the diagnosis of lymphocytic choriomeningitis virus infections and provides epidemiological information on diseases caused by these viruses. Lymphocytic choriomeningitis viruses usually cause a mild cerebral meningitis (inflammation of membranes that envelop the brain) and occasionally a mild pneumonia, but in rare instances may produce severe and even fatal illnesses due to complications from cerebral meningitis and pneumonia.

(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 §866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2311, Jan. 14, 2000]

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