Data-Cyte Plus, Reverse-Cyte, Search-Cyte Reagent Red Blood Cells - STN 103898

STN #: 103898
Proper Name: Reagent Red Blood Cells
Tradename: Reagent Red Blood Cells
Manufacturer: Medion Grifols Diagnostics AG
Indication:

• Data-Cyte Plus 3% Reagent Red Blood Cells is used in tube technique for a careful and complete identification of unexpected antibodies in human blood samples in the diagnosis and treatment of Hemolytic Disease of the Newborn (HDN) and certain blood dyscrasias, as well as in the prevention of transfusion reactions due to infusion of incompatible red blood cells. Most clinically significant antibodies can be identified by agglutination in routine procedures using Reagent Red Blood Cells of known antigenic constitution.
• Data-Cyte Plus, Data-Cyte Plus 2 and Data-Cyte Extend 0.8% Reagent Red Blood Cells are for the identification of unexpected antibodies in gel techniques. Data-Cyte Extend 0.8% cannot detect anti-D For use with the DG Gel 8 System.

Product Information

• Package Insert - Data-Cyte Plus 3% Reagent Red Blood Cells
• Package Insert - Data-Cyte Plus, Data-Cyte Plus 2, and Data-Cyte Extend 0.8 % Reagent Red Blood Cells
• Package Insert- Search-Cyte® Pool 0.8% Reagent Red Blood Cells
• Package Insert - Search-Cyte® Plus and Search-Cyte® TCS 0.8% Reagent Red Blood Cells
• Package Insert - Reverse-Cyte® A1, B 0.8% and Reverse-Cyte® A1, A2 and B 0.8% Reagent Red Blood Cells

Supporting Documents

• May 26, 2023 Approval Letter - Reagent Red Blood
• November 1, 2022 Approval Letter - Reagent Red Blood Cells - STN# 103898/5102
• July 16, 2021 Approval Letter - Reagent Red Blood Cells - STN#103898/5096
• June 30, 2021 Approval Letter - Reagent Red Blood Cells - STN#103898/5097
• December 3, 2019 Approval Letter - Data-Cyte Plus 2, and Data-Cyte Extend  0.8 % Reagent Red Blood Cells
• October 11, 2019 Approval Letter - Reagent Red Blood Cells - STN# 103898/5088
• Supporting Documents older than three years-Reagent Red Blood Cells