Blood Grouping Reagents (Murine Monoclonal) IH-Card (STN# 125094- 097; 125202 - 206)

STN#:
BL 125094 - Anti-A (Murine Monoclonal)(Formulated for Automated Testing)
BL 125096 - Anti-A,B (Murine Monoclonal)(Formulated for Automated Testing)
BL 125097 - Anti-D (Monoclonal)(IgM)(Formulated for Automated Testing)
BL 125202 - Anti-E (Monoclonal)(Formulated for Automated Testing)
BL 125203 - Anti-e (Monoclonal)(Formulated for Automated Testing)
BL 125204 - Anti-K (Monoclonal)(Formulated for Automated Testing)
BL 125205 - Anti-c (Monoclonal)(Formulated for Automated Testing)
BL 125206 - Anti-C (Monoclonal)(Formulated for Automated Testing)
BL 125208 - Reagent Red Blood Cells For Use in Automated Systems
BL 125529 - Anti-Human Globulin (Rabbit/Murine Monoclonal) (Formulated for Automated Testing)
BL 125532 - Anti-B (Murine Monoclonal) (IgG)(Formulated for Automated Testing)
BL 125533 - Anti-D (Monoclonal Blend)(Formulated for Automated Testing)
Proper Name: IH-Card
Tradename:

• Blood Grouping Reagent and Anti-Human Globulin Anti-IgG,-C3d;Polyspecific IH-Card ABO/RhD(DVI+)
• Blood Grouping Reagent IH-Card ABO/D(DVI-)+Rev A1,B
• Blood Grouping Reagent IH-Card ABO/D(DVI+)+Rev A1,B
• Blood Grouping Reagent IH-Card Group ABO
• Blood Grouping Reagent IH-Card ABD(DVI-)-Conf
• Blood Grouping Reagent IH-Card ABD(DVI+)-Conf
• Blood Grouping Reagent IH-Card Group A,B
• Blood Grouping Reagent IH-Card Anti-D (DVI+)
• Blood Grouping Reagent IH-Card Anti-D (DVI-)
• Blood Grouping Reagent IH-Card Anti-e
• Blood Grouping Reagent IH-Card RhD(DVI-) + Phenotype
• Blood Grouping Reagent IH-Card Rh-Phenotype+K

Manufacturer: Bio-Rad Medical Diagnostics GmbH
Indication:

• The IH-Card ABO/RhD(DVI+) is intended for the detection of A (ABO1), B (ABO2) and D (RH1) antigens on human red blood cells and for the detection of immunoglobulins and complement on human red blood cells using the Direct Antiglobulin Test using the IH-System.
• The IH-Card ABO/D(DVI-)+Rev A1,B is intended for the performance of forward and reverse ABO grouping and D (RH1) antigen typing of human red blood samples using the IH-System.
• The IH-Card ABO/D(DVI+)+Rev A1,B is intended for the performance of forward and reverse ABO grouping and D (RH1) antigen typing of human red blood samples using the IH-System.
• The IH-Card Group ABO is intended for the detection of A (ABO1) and B (ABO2) antigens on human red blood cells using the IH-System.
• The IH-Card Group A,B is intended for the detection of A (ABO1) and B (ABO2) antigens on human red blood cells using the IH-System
• The IH-Card ABD(DVI+)-Conf is intended for the detection of A (ABO1), B (ABO2) and D (RH1) antigens on human red blood cells using the IH-System.
• The IH-Card Anti-D (DVI+) is intended for the detection of the D (RH1) antigen on human red blood cells using the IH-System.
• The IH-Card Anti-D (DVI-) is intended for the detection of the D (RH1) antigen on human red blood cells using the IH-System.
• The IH-Card RhD(DVI-) + Phenotype is intended for the detection of D (RH1), C (RH2), E (RH3), ¢ (RH4), and e (RH5) antigens on human red blood cells using the IH-System.
• The IH-Card ABD(DVI-)-Conf is intended for the detection of A (ABO1) and B (ABO2) and D (RH1) antigens on human red blood cells using the IH-System.
• The IH-Card Anti-E is intended for the detection of E (RH3) antigen on human red blood cells using the IH-System.
• The IH-Card Anti-C-E-K is intended for the detection of C (RH2), E (RH3) and K (KEL1) antigens on human red blood cells using the IH-System.
• The IH-Card Rh-Phenotype+K is intended for the detection of C (RH2), E (RH3), ¢ (RH4), e (RH5), and K (KEL1) antigens on human red blood cells using the IH-System.
• The IH-Card Anti-e is intended for the detection of the e (RH5) antigen on the human red blood cells using the IH-System.
   

• Product Information

• Package Insert - IH-Card Group ABO
• Package Insert - IH-Card ABO/D(DVI-)+Rev A1, B
• Packet Insert - IH-Card Rh-Phenotype+K
• Package Insert - IH-Card ABO/RhD(DVI+) (STN#: 125094)
• Package Insert - IH-Card ABD(DVI-)-Conf
• Package Insert - IH-Card RhD(DVI-) + Phenotype
• Package Insert - IH-Card Anti-D (DVI+)
• Package Insert - IH-Card Group A,B
• Package Insert - IH-Card ABO/D(DVI+)+Rev A1, B
• Package Insert - IH-Card Anti-E
• Package Insert - IH-Card Anti-C
• Package Insert - IH-Card ABD(DVI+)-Conf
• Package Insert - IH-Card Anti-C-E-K
• Package Insert - IH-Card Anti-e
• Package Insert - IH-Card Anti-D (DVI-)
• Package Insert - IH-Card Anti-¢
• Package Insert - IH-Card Anti-K

Supporting Documents

• February 28, 2022 Approval Letter - Blood Grouping Reagent (BL 125096-125097, 125202-125206, 125208, 125529, 125532-125533)
• July 20, 2021 Approval Letter - Blood Grouping  Reagent (STN# 125094, et. al)
• March 21, 2019 Approval Letter - IH-Cards (STN#: 125094)
• October 21, 2016 Approval Letter - IH-Cards (STN# 125094)
• October 21, 2016 Summary Basis for Regulatory Action - IH Cards (STN 125094)