U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Vaccines, Blood & Biologics
  3. Diagast Bundled BLA 125616
  1. Vaccines, Blood & Biologics

Diagast Bundled BLA 125616

STN#:  125616
Proper Name: Blood Grouping Reagents Anti Human Globulin Anti-IgG, C3d 
Tradename: None
Manufacturer:  Diagast
Indication:

  • Anti Human Globulin Anti-IgG (Murine Monoclonal) - This reagent is intended for use in the direct antiglobulin test to detect in vivo coating on human red blood cells with IgG and for indirect antiglobulin test for antibody screening and identification, and crossmatch and for erythrocyte phenotyping with blood phenotyping reagents requiring an indirect antiglobulin test method.
  • Anti Human Globulin Anti-C3d (Murine Monoclonal) - This reagent is intended for use in the direct antiglobulin test to detect the in vivo coating of human red blood cells with C3d components. Anti-Human Globulin Anti-C3d only recognizes the complement fragment and, consequently, cannot react with component C4.
  • Anti Human Globulin Anti-IgG, C3d (Murine Monoclonal) - This reagent is intended for use in the direct antiglobulin test to detect the in vivo coating on human red blood cells with IgG and/or C3d components. In addition, to recognizing IgG antibodies and the complement fragment C3d, Anti Human Globulin Anti-IgG, C3d is able to recognize IgM antibodies on the surface of red blood cells since IgM antibodies always fix complement in vivo (and in vitro if the reaction occurs in the presence of complement: i.e., when using a fresh sample).

 

Product Information

Supporting Documents

Back to Top