21 CFR 864.9050 - Blood bank supplies.

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§ 864.9050 Blood bank supplies.
(a) Identification. Blood bank supplies are general purpose devices intended for in vitro use in blood banking. This generic type of device includes products such as blood bank pipettes, blood grouping slides, blood typing tubes, blood typing racks, and cold packs for antisera reagents. The device does not include articles that are licensed by the Center for Biologics Evaluation and Research of the Food and Drug Administration.
(b) Classification. Class I (general controls).
[45 FR 60638, Sept. 12, 1980, as amended at 53 FR 11253, Apr. 6, 1988]

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-09-03; vol. 79 # 170 - Wednesday, September 3, 2014
    1. 79 FR 52195 - Medical Devices; Hematology and Pathology Devices; Classification of Early Growth Response 1 Gene Fluorescence In-Situ Hybridization Test System for Specimen Characterization
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective October 3, 2014. The classification was applicable July 29, 2013.
      21 CFR Part 864

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United States Code

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 864 after this date.

  • 2014-09-03; vol. 79 # 170 - Wednesday, September 3, 2014
    1. 79 FR 52195 - Medical Devices; Hematology and Pathology Devices; Classification of Early Growth Response 1 Gene Fluorescence In-Situ Hybridization Test System for Specimen Characterization
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective October 3, 2014. The classification was applicable July 29, 2013.
      21 CFR Part 864