STN #: 103898
Proper Name: Reagent Red Blood Cells
Tradename: Data- Cyte Plus, Reverse-Cyte, Search-Cyte Pool 0.8% Reagent Red Blood Cells
Manufacturer: Medion Diagnostics AG, License #1740
Indication:

• Search-Cyte Pool 0.8% Reagent Red Blood Cells is for the detection of unexpected antibodies in gel techniques.
• Reverse-Cyte A1, B 0.8% and Reverse-Cyte® A1, A2 and B 0.8% Reagent Red Blood Cells are for the confirmation of ABO Blood grouping in gel techniques.
• Data-Cyte Plus, Data-Cyte Plus 2 and Data-Cyte Extend 0.8 % Reagent Red Blood Cells is for the identification of unexpected antibodies in gel techniques.
• Search-Cyte Plus and Search-Cyte TCS 0.8% Reagent Red Blood Cells are for the detection of unexpected antibodies in gel techniques.

Product Information

• 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

• 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