21 CFR 864, Subpart J - Products Used In Establishments That Manufacture Blood and Blood Products
- § 864.9050 — Blood bank supplies.
- § 864.9100 — Empty container for the collection and processing of blood and blood components.
- § 864.9125 — Vacuum-assisted blood collection system.
- § 864.9145 — Processing system for frozen blood.
- § 864.9160 — Blood group substances of nonhuman origin for in vitro diagnostic use.
- § 864.9175 — Automated blood grouping and antibody test system.
- § 864.9185 — Blood grouping view box.
- § 864.9195 — Blood mixing devices and blood weighing devices.
- § 864.9205 — Blood and plasma warming device.
- § 864.9225 — Cell-freezing apparatus and reagents for in vitro diagnostic use.
- § 864.9245 — Automated blood cell separator.
- § 864.9275 — Blood bank centrifuge for in vitro diagnostic use.
- § 864.9285 — Automated cell-washing centrifuge for immuno-hematology.
- § 864.9300 — Automated Coombs test systems.
- § 864.9320 — Copper sulfate solution for specific gravity determinations.
- § 864.9400 — Stabilized enzyme solution.
- § 864.9550 — Lectins and protectins.
- § 864.9575 — Environmental chamber for storage of platelet concentrate.
- § 864.9600 — Potentiating media for in vitro diagnostic use.
- § 864.9650 — Quality control kit for blood banking reagents.
- § 864.9700 — Blood storage refrigerator and blood storage freezer.
- § 864.9750 — Heat-sealing device.
- § 864.9875 — Transfer set.
Title 21 published on 2012-04-01
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§ 360c - Classification of devices intended for human use
§ 360e - Premarket approval
§ 360j - General provisions respecting control of devices intended for human use
Title 21 published on 2012-04-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 864 after this date.
GPO FDSys XML | Text type regulations.gov FR Doc. 2013-06826 RIN Docket No. FDA-2013-N-0011 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This rule is effective March 26, 2013. 21 CFR Parts 814, 822, 862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886, 888, 890, and 892 The Food and Drug Administration (FDA) is amending certain medical device regulations to correct minor errors in the Code of Federal Regulations (CFR). This action is editorial in nature and is intended to provide accuracy and clarity to the Agency's regulations.