STN: BL 125304-06,125308-09, 125311-14, 125568-69, 125572-73, 125599, 125600, 125601, 125637
Proper Name: Blood Grouping Reagents, Anti-D, Anti-N, Anti-Lea, Anti-Leb , Anti-D
Tradename: ORTHO Sera , ALBAclone
Manufacturer: Alba Bioscience Limited (Alba)
Indication: 

• ORTHO Sera Anti-D (DVI) is for the in vitro detection of human Rh D (DVI) positive red blood cells by the direct agglutination test. Patients and neonates should not be tested with this reagent since it detects partial RhD (DVI).
• ORTHO Sera Anti-D (IAT) is for the in vitro detection of human Rh D positive red blood cells by the indirect antiglobulin test.
• ORTHO Sera Anti-Le^a is for the qualitative in vitro detection of human Lea positive red blood cells by the direct agglutination test.
• ORTHO Sera Anti-Le^b is for the qualitative in vitro detection of human  Leb positive red blood cells by the direct agglutination test.
• ORTHO Sera Anti-N is for the qualitative in vitro detection of human N positive red blood cells by the direct agglutination test.
• ORTHO Sera Anti-S reagent (Anti-MNS3) is for the qualitative in vitro detection of human S positive red blood cells by the indirect antiglobulin test.
• ORTHO Sera Anti-s reagent (Anti-MNS4) is for the qualitative in vitro detection of human s positive red blood cells by the indirect antiglobulin test.
• ORTHO Sera 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.
• ORTHO Sera Anti-Fy^b reagent (Anti-FY2) is for the qualitative in vitro detection of human Fy^b positive red blood cells by the indirect antiglobulin test.
• ORTHO Sera Anti-K reagent (KEL1) is for the qualitative in vitro detection of human K positive red blood cells by the direct agglutination test.
• ORTHO Sera Anti-Jk^a reagent (Anti-JK1) is for the qualitative in vitro detection of human Jk^a positive red blood cells by the direct agglutination test.
• ORTHO Sera Anti-Jk^b reagent (Anti-JK2) is for the qualitative in vitro detection of human Jk^b positive red blood cells by the direct agglutination test.
• ORTHO Sera Anti-P1 reagent (Anti-P1PK1) is for the qualitive in vitro detection of human P1 positive red blood cells by the direct agglutination test.
• ALBAclone Anti-N reagent is for the in vitro detection and identification of human N blood group antigen by direct agglutination.
• ALBAclone Anti-P1 reagent is for the in vitro detection and identification of human P1 positive red blood cells by direct agglutination.
• ALBAclone Anti-Lub reagent is for the in vitro detection and identification of the human Lub blood group antigen by direct agglutination.
• ALBAclone Anti-D (alpha) reagent is for the in vitro detection and identification of human RhD blood group status by direct agglutination
• ALBAclone Anti-D (delta) reagent is for the in vitro detection and identification of human RhD blood group status in donor samples by direct agglutination.
• ALBAclone Anti-D (blend) reagent is for the in vitro detection and identification of human RhD blood group status in donor samples by the indirect antiglobulin test, and in patient samples by direct agglutination, and the indirect antiglobulin test if desired.
• ALBAclone Anti-C reagent is for the in vitro detection and identification of the human C blood group antigen by direct agglutination.
• ALBAclone Anti-E reagent is for the in vitro detection and identification of the human E blood group antigen by direct agglutination.
• ALBAclone Anti-c reagent is for the in vitro detection and identification of the human c blood group antigen by direct agglutination.
• ALBAclone Anti-e reagent is for the in vitro detection and identification of the human e blood group antigen by direct agglutination.
• ALBAcloneAnti-Cw reagent is for the in vitro detection and identification of the human Cw blood group antigen by direct agglutination.
• ALBAclone Anti-K reagent is for the in vitro detection and identification of the human K blood group antigen by direct agglutination.
• ALBAclone Anti-Fyb reagent is for the in vitro detection and identification of human Fyb positive red blood cells by direct agglutination.
• ALBAclone Anti-Jka reagent is for the in vitro detection and identification of the human Jka blood group antigen by direct agglutination.
• ALBAclone Anti-Jkb reagent is for the in vitro detection and identification of the human Jkb blood group antigen by direct agglutination.
• ALBAclone Anti-M reagent is for the in vitro detection and identification of the human M positive red blood cells direct agglutination.

Product Information

• Package Insert - ORTHO Sera Anti-D (IAT) (Monoclonal Blend)
• Package Insert - ORTHO Sera Anti-D (DVI) (Monoclonal)
• Package Insert - ORTHO Sera Anti-N (Murine Monoclonal)
• Package Insert - ORTHO Sera Anti-Le^a, Le^b (Murine Monoclonal)
• Package Insert - ORTHO Sera - Anti-S, Anti-s (Monoclonal) (IgG)
• Package Insert - ORTHO Sera - Anti Fy^a (Monoclonal) (IgG), Fy^b
• Package Insert - ORTHO Sera - Anti - K (Monoclonal)
• Package Insert - ORTHO Sera - Anti-Jk^a, Anti-Jk^b (Monoclonal)
• Package Insert - ORTHO Sera -Anti -P1 (Murine Monoclonal)
• Package Insert - ALBAclone - Anti - K (Monoclonal)
• Package Insert-ALBAclone - Anti - c (Human-Murine Monoclonal IgM)
• Package Insert-ALBAclone - Anti-C (Human-Murine Monoclonal)
• Package Insert - ALBAclone - Anti-C^w (Human-Murine Monoclonal IgM)
• Package Insert - ALBclone - Anti -D Alpha (Human-Murine Monoclonal IgM)
• Package Insert - ALBclone - Anti-E (Human-Murine Monoclonal IgM)
• Package Insert - ALBAclone - Anti - M (Murine Monoclonal IgG)
• Package Insert - ALBAclone - Anti-P1 (Murine Monoclonal)
• Package Insert - ALBAclone Anti-D blend (Human-Murine Monoclonal IgM-IgG Blend)
• Package Insert - ALBAclone Anti-D delta (Human-Murine Monoclonal IgM-IgM)
• Package Insert - ALBAclone - Anti-e (Human-Murine Monoclonal)
• Package Insert - ALBAclone - Anti-Fy^b (Human-Murine Monoclonal)
• Package Insert - ALBclone - Anti-Jk^b (Monoclonal)
• Package Insert - ALBAclone Anti-Lu^b (Murine Monoclonal IgG)
• Package Insert - ALBAclone Anti-N (Murine Monoclonal)
• Package Insert - ALBAclone Anti-Jk^a (Monoclonal)
   

Supporting Documents

• May 11, 2020 Approval Letter - Anti - M (Murine Monoclonal IgG) STN#125308-56
• March 13, 2020 Approval Letter - ALBAclone BL 125304-69 et al.
• March 13, 2020 Approval Letter - ALBAclone STN#125309-64
• December 17, 2019 Approval Letter - ORTHO Sera
• July 8, 2019 Approval Letter - ORTHO Sera
• June 20, 2017 Summary Basis for Regulatory Action Template - ORTHO Sera
• June 16, 2017 Approval Letter - ORTHO Sera