Blood Grouping Regents, BL 101728-34;103292; 125848-125855
The FDA updated or issued documentation regarding Blood Grouping Regents under BL numbers 101728-34, 103292, and 125848-125855 for testing human red blood cells via room temperature saline tube tests.
This affects manufacturers of blood grouping reagents, clinical laboratory personnel performing blood typing, and regulatory affairs professionals managing Biologics License Applications (BLAs) for immunohematology products.
The listing of specific Biologics License numbers associated with a standardized testing method (room temperature saline tube test) suggests a maintenance of regulatory status or a technical update for these reagents. For compliance departments, this underscores the necessity of maintaining precise methodology documentation for diagnostic reagents used in pre-transfusion or diagnostic settings. The source does not specify if this is a new approval or an amendment, but the specificity of the test type indicates strict adherence to validated protocols is required.
Regulatory and QA teams should ensure that standard operating procedures (SOPs) for these reagents align strictly with the room temperature saline tube test method. Internal audits should verify that the specific Biologics License (BL) numbers listed are correctly captured in current facility inventory and labeling systems.
Blood Grouping Regents, BL 101728-34;103292; 125848-125855<br> Reagent is used for testing human red blood cells by the room temperature saline tube test
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