Data-Cyte Plus, Reverse-Cyte, Search-Cyte Reagent Red Blood Cells - STN 103898
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 Grifols Diagnostics AG
Indication:
- Search-Cyte Pool 0.8% Reagent Red Blood Cells is for the detection and titration 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 for the confirmation of ABO Blood grouping and for titration of antibodies in gel techniques.
- Data-Cyte Plus, Data-Cyte Plus 2 and Data-Cyte Extend 0.8 % Reagent Red Blood Cells is for the identification and titration of unexpected antibodies in gel
techniques. Data-Cyte® Extend 0.8% cannot detect anti-D. It is also for use with the DG Gel 8 System. - 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
- 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