CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 864—HEMATOLOGY AND PATHOLOGY DEVICES > SUBPART J—Products Used In Establishments That Manufacture Blood and Blood Products (§864.9050 to §864.9875) > 864.9700—Blood storage refrigerator and blood storage freezer.

864.9700—Blood storage refrigerator and blood storage freezer.

(a) Identification. A blood storage refrigerator and a blood storage freezer are devices intended for medical purposes that are used to preserve blood and blood products by storing them at cold or freezing temperatures.
(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.

Code of Federal Regulations

[45 FR 60650, Sept. 12, 1980, as amended at 63 FR 59226, Nov. 3, 1998]