Reagent Red Blood Cells for use with the IH-System

STN#: 125208
Proper Name: IH-Cell A1 & B, IH-Cell A2, IH-Cell I-II, IH-Cell I-II-III, IH-Cell Pool, IH-Panel 11, IH-Panel 11 Papain, IH-Panel Plus 6
Tradename: Reagent Red Blood Cells
Manufacturer: Bio-Rad Medical Diagnostics GmbH
Indication:

• IH-Cell A1&B and IH-Cell A2 are intended for the detection of antibodies to ABO blood group antigens on human red blood cells. For In Vitro Diagnostic Use.
• IH-Cell I-II and IH-Cell I-II-III are intended for the detection of antibodies to human red blood cell antigens in patients and donors. The IH-Cell Pool is intended for the detection of antibodies to human red blood cell antigens in donors. For In Vitro Diagnostic Use.
• IH-Panel 11, IH-Panel 11 Papain and IH-Panel Plus 6 are intended for the identification of antibodies to human red blood cell antigens. IH-Panel 11 Papain is intended for use as a supplemental test for complex antibody identification. For In Vitro Diagnostic Use.

Product Information

• Package Insert - Reagent Red Blood Cells IH-Cell A1
• Package Insert - Reagent Red Blood Cells IH-Cell A1&B and IH-Cell A2
• Package Insert - Reagent Red Blood Cells IH-Cell I-II-III / IH-Cell I-II / IH-Cell Pool
• Package Insert - Reagent Red Blood Cells IH-Panel 11 / IH-Panel 11 Papain / IH-Panel Plus 6

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 - Reagent Red Blood Cells for use with the IH-System
• Supporting Documents older than three years - Reagent Red Blood Cells for use with the IH-System