21 CFR 866.3415
§ 866.3415
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 866.3415, § 866.3415, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89549
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Full text
(a) Identification. Pseudomonas spp. serological reagents are devices that consist of antigens and antisera, including antisera conjugated with a fluorescent dye (immunofluorescent reagents), used to identify Pseudomonas spp. from clinical specimens or from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Pseudomonas. Pseudomonas aeruginosa is a major cause of hospital-acquired infections, and has been associated with urinary tract infections, eye infections, burn and wound infections, blood poisoning, abscesses, and meningitis (inflammation of brain membranes). Pseudomonas pseudomallei causes melioidosis, a chronic pneumonia.
(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 § 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.