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Title 21 Part 864 → Subpart F → §864.5425

Title 21 → Chapter I → Subchapter H → Part 864 → Subpart F → §864.5425

Electronic Code of Federal Regulations e-CFR

Title 21 Part 864 → Subpart F → §864.5425

e-CFR data is current as of January 27, 2020

Title 21Chapter ISubchapter HPart 864Subpart 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]