21 CFR 866.4800
§ 866.4800 Radial immunodiffusion plate.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 866.4800, § 866.4800 Radial immunodiffusion plate, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89604
- Permanent ID
ys:prov:89604@1- SHA-256
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Full text
(a) Identification. A radial immunodiffusion plate for clinical use is a device that consists of a plastic plate to which agar gel containing antiserum is added. In radial immunodiffusion, antigens migrate through gel which originally contains specific antibodies. As the reagents come in contact with each other, they combine to form a precipitate that is trapped in the gel matrix and immobilized.
(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.