Diagast Bundled BLA 125615, 125619 to 125626

STN#:  125615, 125619 to 125626
Proper Name: Blood Grouping Reagents
Tradename: Anti-A (ABO1), Anti-B (ABO2), Anti-A,B (ABO3), Anti-D (RH1) IgG, Anti-D (RH1) IgM, Anti-D (RH1) IgM/IgG, Anti-C (RH2), Anti-c (RH4),Anti-E (RH3),Anti-e (RH5),Anti-K (KEL1)
Manufacturer: Diagast
Indication:

• Blood Grouping Reagent, Anti-A (Murine Monoclonal) - This reagent is designed to determine the presence of ABO system blood group antigen A on the surface of human red blood cells by manual method.
• Blood Grouping Reagent, Anti-B (Murine Monoclonal) - This reagent is designed to determine the presence of ABO system blood group antigen B on the surface of human red blood cells by manual method.
• Blood Grouping Reagent, Anti-D (Human/Murine Monoclonal); Blood Grouping Reagent, Anti-D (Human/Murine Monoclonal  Blend) - These reagents are designed to determine the presence of the blood Rhesus antigen D (RH1) on the surface of human red blood cells by manual method
• Blood Grouping Reagent, Anti-C (Human/Murine Monoclonal) - This reagent is designed to determine the presence of the blood group antigen C (Rh2) on the surface of human red blood cells by manual method.
• Blood Grouping Reagent, Anti-E (Human/Murine Monoclonal) - This reagent is designed to determine the presence of the blood group antigen E (Rh3) on the surface of human red blood cells by manual method.
• Blood Grouping Reagent, Anti-c (Human/Murine Monoclonal) - This reagent is designed to determine the presence of the blood group antigen c (Rh4) on the surface of human red blood cells by manual method.
• Blood Grouping Reagent, Anti-e (Human/Murine Monoclonal) - This reagent is designed to determine the presence of the blood group antigen e (Rh5) on the surface of human red blood cells by manual method.
• Blood Grouping Reagent, Anti-K (Human/Murine Monoclonal) - This reagent is designed to determine the presence of the blood group antigen K on the surface of human red blood cells by manual method.

Product Information

• Package Insert - Anti-D (RH1) IgM/IgG
• Package Insert - Anti-C (RH2), Anti-c (RH4),Anti-E (RH3),Anti-e (RH5),Anti-K (KEL1)
• Package Insert - Anti-D (RH1) IgG, Anti-D (RH1) IgM
• Package Insert - Anti-A (ABO1), Anti-B (ABO2), Anti-A,B (ABO3)

Supporting Documents

• December 9, 2021 Approval Letter - Anti-D (RH1) IgM/IgG - 125615/8*
• April 23, 2020 Approval Letter - Anti-D (RH1) IgM/IgG - 125621/5
• December 10, 2019 - Approval Letter - Anti-D (RH1) IgM/IgG 125621/2
• Summary Basis for Regulatory Action - Diagast Bundled BLA 125615, 125619 to 125626
• February 2, 2018 Approval Letter - Diagast Bundled BLA 125615, 125619 to 125626