Blood Grouping definition

Blood Grouping means characterizing blood-group antigens and antibodies to such antigens in a given blood sample.
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Blood Grouping means characterization of the blood-group antigens and antibodies to such antigens set forth on Schedule 1.9 in a given blood sample. Schedule 1.9 may be updated from time to time pursuant to Section 4.3.3 and Section 4.3.4.
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Blood Grouping means characterization of the blood-group antigens and antibodies to such antigens set forth on Schedule
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Examples of Blood Grouping in a sentence

  • If the test, using Anti-D Blood Grouping Rea- gent, is positive, the container may be labeled ‘‘Rh Positive.’’ If the test is negative, the results shall be confirmed by further testing which shall include tests for the ‘‘weak D (formerly Du).’’ Blood may be labeled ‘‘Rh Negative’’ if further testing is negative.

  • Only those Anti-A and Anti-B Blood Grouping Reagents li- censed under, or that otherwise meet the requirements of, the regulations of this subchapter shall be used, and the technique used shall be that for which the serum is specifically designed to be effective.

  • The final container label of all Blood Grouping Reagents shall be completely white, except that all or a portion of the final container label of the following Blood Grouping Reagents may be color coded with the specified color which shall be a visual match to a specific color sample designated by the Director, Center for Biologics Evaluation and Research.

  • DIAGAST submitted a bundled original Biologics License Application requesting approval to manufacture the Blood Grouping Reagents listed in Table 1.

  • Only those Anti-A and Anti-B Blood Grouping Reagents li- censed under, or that otherwise meet the requirements of, the regulations of this subchapter shall be used, and the technique used shall be that for which the serum is specifically designed to be effective.(c) Determination of the Rh factors.

  • DIAGAST will manufacture the seven Blood Grouping Reagents (BGRs) at their licensed facility (Establishment Registration Number 3006261638) in Loos, France for Grifols Diagnostic Solutions Inc who will distribute the products.

  • The submissions consist of: • Three Biologics License Applications (BLAs): one Anti-Human Globulin and two Blood Grouping Reagents (BGRs).• Ten Efficacy Supplements: one Anti-Human Globulin, eight BGRs, and one Reagent Red Blood Cells (RRBCs).• Four 510(k) premarket notifications for the analyzer, software, control and neutral card.

  • We propose to maintain the current exceptions to the sterility test requirements in § 610.12(g)(4)(i) for Whole Blood, Cryoprecipitated AHF, Platelets, Red Blood Cells, Plasma, Source Plasma, Smallpox Vaccine, Reagent Red Blood Cells, Anti-Human Globulin, and Blood Grouping Reagent.

  • The clinical benefits using the Ortho MTS Anti-IgG Gel Card as the test method for the Ortho™ Sera Anti-Fyb Blood Grouping Reagent include reduction in errors associated with subjective interpretation due to manual tube method testing and the capability to review stored test results, if necessary.

  • Meetings with FDA:Alba submitted a pre-submission meeting request to FDA (reference PTS # PS002250) on September 5, 2013, to discuss 14 Blood Grouping Reagents (BGR), both monoclonal and polyclonal, to be marketed under the trade name ORTHO™ Sera for use with the Ortho ID-Micro Typing System™ gel cards manufactured byOrtho-Clinical Diagnostics.


More Definitions of Blood Grouping

Blood Grouping shall have the meaning set forth in the OCD Agreement on the date hereof.
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