Blood Grouping Regents, BL 101728-34;103292; 125848-125855

BL: 101728 – 34, 103292; 125848-125855
Proper Name: N/A
Tradename: Blood Grouping Reagent
Manufacturer: American National Red Cross
Indication:

• Anti-C (Human/Murine Monoclonal) is used for the in vitro detection of the C (RH2), E (RH3), and c¯(RH4) antigens respectively, on human red blood cells by direct agglutination using the manual tube testing method.
• Anti-E (Monoclonal) is used for the in vitro detection of the C (RH2), E (RH3), and c¯(RH4) antigens respectively, on human red blood cells by direct agglutination using the manual tube testing method.
• Anti-c¯ (Monoclonal) is used for the in vitro detection of the C (RH2), E (RH3), and c¯(RH4) antigens respectively, on human red blood cells by direct agglutination using the manual tube testing method.
• Anti-k¯ (Monoclonal) (IgG) is used for the in vitro detection of the k¯(KEL2) antigen on human red blood cells by the Indirect Antiglobulin Test (IAT).
• Anti-Jk^a (Monoclonal) is used for the in vitro detection of the Jka (JK1) and Jkb (JK2) antigens respectively, on human red blood cells by direct agglutination using the manual tube test.
• Anti-Jk^b (Monoclonal) is used for the in vitro detection of the Jka (JK1) and Jkb (JK2) antigens respectively, on human red blood cells by direct agglutination using the manual tube test.
• Anti-S (Monoclonal)is used for the in vitro detection of the S (MNS3) and s¯(MNS4) antigens respectively, on human red blood cells by direct agglutination using the manual tube testing method.
• Anti-s¯ (Monoclonal) is used for the in vitro detection of the S (MNS3) and s¯(MNS4) antigens respectively, on human red blood cells by direct agglutination using the manual tube testing method.
• Anti-M Blood Grouping Reagent is used for testing human red blood cells by the room temperature saline tube test
• Ant-Kpb Blood Grouping Reagent is used for testing human red blood cells by the indirect antiglobulin test
• Anti-kpa Blood Grouping Reagent is used for testing human red blood cells by the indirect antiglobulin test
• Anti-K Blood Grouping Reagent is used for testing human red blood cells by the indirect antiglobulin test
• Anti-S Blood Grouping Reagent is used for testing human red blood cells by the room temperature indirect antiglobulin test.
• Anti-k Blood Grouping Reagent is used for testing human red blood cells by the indirect antiglobulin test
• Anti-Fya Blood Grouping Reagent is used for testing human red blood cells by the indirect antiglobulin test
• Anti-s Blood Grouping Reagent is used for testing human red blood cells by the room temperature indirect antiglobulin test.

Product Information

• Directions For Use Anti-C, Anti-E, and Anti-c (BL 125848 - BL 125850)
• Directions For Use Anti-k¯  (BL 125851)
• Directions for Use Anti-Jk^a and Anti-Jk^b (BL 125852 - BL 125853)
• Directions For Use Anti-S and Anti-s (BL 125854 and BL 125855)
• Package Insert -Anti-M 101732
• Package Insert - Anti - Kpb 101731
• Package Insert - Anti-Kpa 101730
• Package Insert - Anti - K 103292
• Package Insert - Anti - S 101734
• Package Insert - Anti - k 101729
• Package Insert - Anti - Fya 101728
• Package Insert - Anti-s 101733

Supporting Document

• November 21, 2025 Approval Letter Blood Grouping Reagents Anti-C (Human/Murine Monoclonal) (BL 125848)
• November 21, 2025 Approval Letter Blood Grouping Reagents, Anti-E (Human/Murine Monoclonal) (BL 125849)
• November 21, 2025 Approval Letter Blood Grouping Reagent, Anti-c (Human/Murine Monoclonal) (BL 125850)
• November 21, 2025 Approval Letter  Blood Grouping Reagents Anti-k (Human/Murine Monoclonal) (IgG) (BL 125851)
• November 21, 2025 Approval Letter Blood Grouping Reagent, Anti-Jk^a (Human/Murine Monoclonal) (BL 125852)
• November 21, 2025 Approval Letter Blood Grouping Reagent, Anti-Jk^b (Human/Murine Monoclonal) (BL 125853)
• November 21, 2025 Approval Letter Blood Grouping Reagent, Anti-S (Human/Murine Monoclonal) (BL125854)
• November 21, 2025 Approval Letter Blood Grouping Reagent, Anti-s (Human/Murine Monoclonal) (BL 125855)
• November 13, 2025 Summary Basis for Regulatory Action - Blood Grouping Reagents Anti-C (Monoclonal), Anti-E (Monoclonal), Anti-c (Monoclonal), Anti-k (Monoclonal) (IgG), Anti-Jk^a (Monoclonal), Anti-Jk^b (Monoclonal), Anti-S (Monoclonal), Anti-s (Monoclonal) - BL 125848 to 125855
• April 24, 2019 Approval Letter - Blood Grouping Regents, BL 101728-34 & 103292