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21 CFR 866.3900

§ 866.3900 Varicella-zoster virus serological reagents.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 866.3900, § 866.3900 Varicella-zoster virus serological reagents, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89571
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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).

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.