Blood Grouping Reagent, Anti-B (Murine Monoclonal) (IgG) (Formulated for Automated Testing)
STN#: 125532
Proper Name: Blood Grouping Reagent, Anti-B (Murine Monoclonal) (IgG) (Formulated for Automated Testing)
Tradename: IH-Card
Manufacturer: Bio-Rad Medical Diagnostics GmbH
Indication:
- 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 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 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 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 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.
Product Information
- Package Insert - IH-Anti-D (RH1) Blend
- Package Insert - IH-Card ABD(DVI+)-Conf
- Package Insert - IH - Card Group ABO
- Package Insert - IH-Card ABO/RhD (DVI+)
- Package Insert - IH-Card ABO/D(DVI-)+Rev A1, B
- Package Insert - IH-Card ABD(DVI-)-Conf
Supporting Documents
- February 28, 2022 Approval Letter - Blood Grouping Reagent (BL 125096-125097, 125202-125206, 125208, 125529, 125532-125533)
- October 21, 2016 Approval Letter - IH-Card
- October 21, 2016 Summary Basis for Regulatory Action - IH-Card BGR Products