![]() |
Code of Federal Regulations (Last Updated: July 5, 2024) |
![]() |
Title 21 - Food and Drugs |
![]() |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
![]() |
SubChapter H - Medical Devices |
![]() |
Part 864 - Hematology and Pathology Devices |
![]() |
Subpart F - Automated and Semi-Automated Hematology Devices |
§ 864.5425 - Multipurpose system for in vitro coagulation studies.
Latest version.
-
§ 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 (performance standards). 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]