21 CFR 866.3490
§ 866.3490 Rhinovirus serological reagents.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 866.3490, § 866.3490 Rhinovirus serological reagents, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89553
- Permanent ID
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Full text
(a) Identification. Rhinovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rhinovirus in serum. The identification aids in the diagnosis of rhinovirus infections and provides epidemiological information on diseases caused by these viruses. Rhinoviruses cause common colds.
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.