ORTHO Sera Anti-D (IAT) (Monoclonal Blend) Blood Grouping Reagent
STN: 125314
Proper Name: Blood Grouping Reagent
Tradename: ORTHO Sera Anti-D (IAT) (Monoclonal Blend) Blood Grouping Reagent
Manufacturer: Alba Bioscience Limited (Alba)
Indication:
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The Anti-D (IAT) reagent (Anti-RH1) is for the qualitative in vitro detection of human RhD positive red blood cells by the indirect antiglobulin test.
Product Information
- Package Insert - ALBAclone Anti-D fusion (Anti-D)
- Package Insert - ORTHO Sera Anti-D (IAT) (Monoclonal Blend) Blood Grouping Reagent
Supporting Documents
- April 19, 2021 Approval Letter - Blood Grouping Reagents Anti-D, Anti-Fya, Anti-S, Anti-K
- June 22, 2018 Approval Letter - ALBAclone Anti-D Fusion (Anti-D)
- Summary Basis for Regulatory Action - ALBAclone Anti-D Fusion (Anti-D)