Source: https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&mc=true&r=PART&n=pt21.7.606
Timestamp: 2020-08-14 22:20:48
Document Index: 743834885

Matched Legal Cases: ['art 606', '§606', '§606', '§606', '§606', '§606', '§606', '§610']

Title 21 → Chapter I → Subchapter F → Part 606
§606.3 Definitions.
§606.20 Personnel.
§606.120 Labeling, general requirements.
§606.122 Circular of information.
§606.140 Laboratory controls.
§606.151 Compatibility testing.
(c) The statement “Do Not Add Medications” or an explanation concerning allowable additives.
(e) A statement that the product was prepared from blood that was found negative when tested for relevant transfusion-transmitted infections, as required under §610.40 of this chapter (include each test that was performed).
(f) The statement: “Warning: The risk of transmitting infectious agents is present. Careful donor selection and available laboratory tests do not eliminate the hazard.”
(2) The statement: “Usually contains at least 150 milligrams of fibrinogen”; or, alternatively, the average fibrinogen level determined by assay of representative units.
(4) Instructions to thaw the product for no more than 15 minutes at a temperature of between 30 and 37 °C.
(8) The statement: “Good patient management requires monitoring treatment responses to Cryoprecipitated AHF transfusions with periodic plasma factor VIII or fibrinogen assays in hemophilia A and hypofibrinogenemic recipients, respectively.”