21 CFR 864.5425
§ 864.5425 Multipurpose system for in vitro coagulation studies.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 864.5425, § 864.5425 Multipurpose system for in vitro coagulation studies, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89339
- Permanent ID
ys:prov:89339@1- SHA-256
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Full text
(a) Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.
(b) Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 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.