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Code · CFR · Title 21 — Food and Drugs · Part 866 — Immunology and Microbiology Devices · § 866.3900

§ 866.3900. Varicella-zoster virus serological reagents.

108 words·~1 min read·/us/cfr/t21/s§ 866.3900·

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(a)Identification. Varicella-zoster virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to varicella-zoster in serum. The identification aids in the diagnosis of diseases caused by varicella-zoster viruses and provides epidemiological information on these diseases. Varicella (chicken pox) is a mild, highly infectious disease, chiefly of children. Zoster (shingles) is the recurrent form of the disease, occurring in adults who were previously infected with varicella-zoster viruses. Zoster is the response (characterized by a rash) of the partially immune host to a reactivation of varicella viruses present in latent form in the patient's body.
(b)Classification. Class II (performance standards).
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