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-Fya, Anti-Jka, Anti-Jkb, Anti-S, Anti-s, Anti-K, Anti-P1
Tradename: ALBAcloneR, Anti-Fya; Anti-Jka; Anti-Jkb; Anti-S; Anti-s; Anti-K; Anti-P1
Manufacturer: Alba Bioscience Limited.
Indication:
- The Anti-Fya reagent (Anti-FY1) is for the qualitative in vitro detection of human Fya positive red blood cells by the indirect antiglobulin test.
- The Anti-Jka reagent is for the in vitro detection and identification of the human Jka blood group antigen by direct agglutination.
- The Anti-Jkb reagent is for the in vitro detection and identification of the human Jkb 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.
- 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
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Content current as of:
04/22/2021
