21 C.F.R. § 864.5425 Multipurpose system for in vitro coagulation studies.
Title 21 - Food and Drugs
(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 (performance standards). [45 FR 60599, Sept. 12, 1980]
Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart F—Automated and Semi-Automated Hematology Devices
§ 864.5425 Multipurpose system for in vitro coagulation studies.