Section 864.5425 - Multipurpose system for in vitro coagulation studies(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 .45 FR 60599, Sept. 12, 1980, as amended at 84 FR 71799 , Dec. 30, 2019