Blood Grouping Reagent, Anti-D (Monoclonal Blend) (Formulated for Automated Testing)

STN#:125533
Proper Name: Blood Grouping Reagent, Anti-D (Monoclonal Blend) (Formulated for Automated Testing)
Tradename: IH-Anti-D (RH1) Blend
Manufacturer: Bio-Rad Medical Diagnostics GmbH
Indication:

• IH-Anti-D (RH1) Blend is intended to be used with the IH-Card AHG Anti-IgG to detect the D (RH1) antigen on human red blood cells, including weak D and partial D (DVI) by the indirect antiglobulin test using the IH-System.

Product Information

• Package Insert - IH-Anti-D (RH1) Blend

Supporting Documents

• February 28, 2022 Approval Letter - Blood Grouping Reagent (BL 125096-125097, 125202-125206, 125208, 125529, 125532-125533)
• March 21, 2019 Approval Letter - IH-Anti-D (RH1) Blend
• October 21, 2016 Approval Letter - IH-Anti-D (RH1) Blend
• October 20, 2016 Summary Basis for Regulatory Action - IH-Anti-D (RH1) Blend