21 CFR 864.9600
§ 864.9600 Potentiating media for in vitro diagnostic use.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 864.9600, § 864.9600 Potentiating media for in vitro diagnostic use, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89426
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Full text
(a) Identification. Potentiating media for in vitro diagnostic use are media, such as bovine albumin, that are used to suspend red cells and to enhance cell reactions for antigen-antibody testing.
(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.