Source: https://www.law.cornell.edu/cfr/text/21/864.9160
Timestamp: 2015-10-07 06:55:32
Document Index: 482686162

Matched Legal Cases: ['art 864', '§ 864', '§ 864', 'art 807', '§ 864', '§ 351', '§ 360', '§ 360', '§ 360', '§ 360', '§ 371']

21 CFR 864.9160 - Blood group substances of nonhuman origin for in vitro diagnostic use. | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter H › Part 864 › Subpart J › Section 864.9160 21 CFR 864.9160 - Blood group substances of nonhuman origin for in vitro diagnostic use.
§ 864.9160
§ 864.9160 Blood group substances of nonhuman origin for in vitro diagnostic use.
Identification. Blood group substances of nonhuman origin for in vitro diagnostic use are materials, such as blood group specific substances prepared from nonhuman sources (e.g., pigs, cows, and horses) used to detect, identify, or neutralize antibodies to various human blood group antigens. This generic type of device does not include materials that are licensed by the Center for Biologics Evaluation and Research of the Food and Drug Administration. (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.
[45 FR 60640, Sept. 12, 1980, as amended at 53 FR 11253, Apr. 6, 1988; 63 FR 59225, Nov. 3, 1998] This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.United States CodeU.S. Code: Title 21 - FOOD AND DRUGS§ 351 - Adulterated drugs and devices§ 360 - Registration of producers of drugs or devices§ 360c - Classification of devices intended for human use§ 360e - Premarket approval§ 360j - General provisions respecting control of devices intended for human use§ 371 - Regulations and hearings