Electronic Code of Federal Regulations
|
e-CFR data is current as of January 15, 2021 |
Title 21 → Chapter I → Subchapter H → Part 864 → Subpart F → §864.5425 |
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.
(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]