STN #:
BL 125314 - Anti-D (Monoclonal Blend)
BL 125567 - Anti-Fya (Monoclonal) (IgG)
BL 125570 - Anti-S (Monoclonal) (IgG)
BL 125572 - Anti-K (Monoclonal)

Proper Name: Blood Grouping Reagents, Anti-Fy^a, Anti-Jk^a, Anti-Jk^b, Anti-S, Anti-s, Anti-K, Anti-P1
Tradename: ALBAclone^R, Anti-Fy^a; Anti-Jk^a; Anti-Jk^b; Anti-S; Anti-s; Anti-K; Anti-P1
Manufacturer: Alba Bioscience Limited.
Indication:

• The Anti-Fy^a reagent (Anti-FY1) is for the qualitative in vitro detection of human Fy^a positive red blood cells by the indirect antiglobulin test.
• The Anti-Jk^a reagent is for the in vitro detection and identification of the human Jk^a blood group antigen by direct agglutination.
• The Anti-Jk^b reagent is for the in vitro detection and identification of the human Jk^b blood group antigen by direct agglutination.
• The Anti-S reagent (Anti-MNS3) is for the qualitative in vitro detection of human S positive red blood cells by the indirect antiglobulin test.
• The Anti-s reagent is for the in vitro detection and identification of the human s blood group antigen by Indirect Antiglobulin Test.
• The Anti-K reagent (KEL1) is for or the qualitative in vitro detection of human K positive red blood cells by the direct agglutination test.
• The Anti-P1 reagent is for the in vitro detection and identification of human P1 positive red blood cells by direct agglutination.

Product Information

• Package Insert - Blood Grouping Reagent - Anti-Fy^a
• Package Insert -  Blood Grouping Reagent ORTHO Sera Anti-Fy^a,Fy^b
• Package Insert - Blood Grouping Reagent - Anti-Jk^a
• Package Insert - Blood Grouping Reagent - Anti-Jk^b
• Package Insert - Blood Grouping Reagent - Anti-S
• Package Insert - Blood Grouping Reagent - Anti-s
• Package Insert - Blood Grouping Reagent ORTHO Sera Anti-S, Anti-s
• Package Insert - Blood Grouping Reagent - Anti-K
• Package Insert - Blood Grouping Reagent ORTHO Sera Anti- K
• Package Insert - Blood Grouping Reagent - Anti-P1

Supporting Documents

• April 19, 2021 Approval Letter - Blood Grouping Reagents Anti-D, Anti-Fya, Anti-S, Anti-K
• April 18, 2019 Approval Letter - Blood Grouping Reagents, Anti-Fya, Anti-Jka, Anti-Jkb, Anti-S, Anti-s, Anti-K, Anti-P1
• Summary Basis for Regulatory Action - Blood Grouping Reagent - BL125567/3-73/3
• Summary Basis for Regulatory Action - Blood Grouping Reagents Anti-Fya, Anti-Fyb, Anti-Jka, Anti-Jkb, Anti-S, Anti-s, Anti-K, Anti-P1
• March 16, 2017 Approval Letter - Blood Grouping Reagents, Anti-Fya, Anti-Fyb, Anti-Jka, Anti-Jkb, Anti-S, Anti-s, Anti-K, Anti-P1