DG Gel Card 125445, 125449, 125450 - 125457
The FDA has provided product approval information for DG Gel 8 blood grouping cards designed to determine human A and B antigens in multiple samples, as well as A, B, and D antigens, using the DG Gel System. These products are intended for in vitro diagnostic use in identifying red blood cell antigens.
The source identifies these products for use with the DG Gel System, affecting manufacturers of blood grouping reagents, laboratory personnel in transfusion medicine, and regulatory professionals overseeing immunohematology diagnostics.
This approval expands or confirms the availability of specific diagnostic tools for blood group determination within a standardized gel system. It suggests a continued regulatory focus on ensuring the specificity of antigen detection in multi-sample formats, which is critical for pre-transfusion testing and blood bank safety workflows. Operationally, this necessitates strict adherence to the validated DG Gel System parameters to ensure diagnostic accuracy.
Regulatory and Quality teams should confirm that existing standard operating procedures for blood grouping and antigen determination align with the specific indications for the DG Gel 8 AB and A/B/D cards. Ensure compatibility protocols with the DG Gel System are verified prior to implementation in clinical workflows.
Product approval information is for:<br> •DG Gel 8 AB (x4) card is for the determination of human A and B antigen on the surface of red blood cells in four separate blood samples. For use with the DG Gel System. For in vitro diagnostic use.<br> •DG Gel 8 A/B/D card is for the determination of human A, B and
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