21 CFR 866.4600
§ 866.4600 Ouchterlony agar plate.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 866.4600, § 866.4600 Ouchterlony agar plate, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89601
- Permanent ID
ys:prov:89601@1- SHA-256
c61d8f776715422d8ccb6a7511c659b49edd39e6527dfb7d0f21ac20d90cbc05
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Full text
(a) Identification. An ouchterlony agar plate for clinical use is a device containing an agar gel used to examine antigen-antibody reactions. In immunodiffusion, antibodies and antigens migrate toward each other through gel which originally contained neither of these reagents. As the reagents come in contact with each other, they combine to form a precipitate that is trapped in the gel matrix and is 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.