21 CFR 866.3225
§ 866.3225 Enterovirus nucleic acid assay.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 866.3225, § 866.3225 Enterovirus nucleic acid assay, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89507
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Full text
(a) Identification. An enterovirus nucleic acid assay is a device that consists of primers, probes, enzymes, and controls for the amplification and detection of enterovirus ribonucleic acid (RNA) in cerebrospinal fluid (CSF) from individuals who have signs and symptoms consistent with meningitis or meningoencephalitis. The detection of enterovirus RNA, in conjunction with other laboratory tests, aids in the clinical laboratory diagnosis of viral meningitis caused by enterovirus.
(b) Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Nucleic Acid Amplification Assay for the Detection of Enterovirus RNA.” See § 866.1(e) for the availability of this guidance document.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.