21 CFR 866.2160
§ 866.2160 Coagulase plasma.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 866.2160, § 866.2160 Coagulase plasma, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89448
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Full text
(a) Identification. Coagulase plasma is a device that consists of freeze-dried animal or human plasma that is intended for medical purposes to perform coagulase tests primarily on staphylococcal bacteria. When reconstituted, the fluid plasma is clotted by the action of the enzyme coagulase which is produced by pathogenic staphylococci. Test results are used primarily as an aid in the diagnosis of disease caused by pathogenic bacteria belonging to the genus Staphylococcus and provide epidemiological information on disease caused by these microorganisms.
(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.