U.S. Code of Federal Regulations
Regulations most recently checked for updates: Aug 28, 2025
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All TitlesTitle 21Chapter IPart 864Subpart F - Subpart F—Automated and Semi-Automated Hematology Devices
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(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.
