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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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July 19, 2013 Approval Letter- Reagent Red Blood Cells

Our STN: BL 103898/5063
Medion Grifols Diagnostics AG
Attention: Peter Schwind, PhD
Bonnstrasse 9
CH-3186 Duedingen
Switzerland

Dear Dr. Schwind:

We have approved your request to supplement your biologics license application for Reagent Red Blood Cells to include the manufacture of the 0.8% Reagent Red Blood Cell products listed below for use with the DG Gel® 8 Cards manufactured by Diagnostics Grifols, S.A.

Reagent Red Blood Cell Product

Intended Use

Reverse-Cyte® A1, B 0.8%


Reverse-Cyte® A1, A2, B 0.8%

For the confirmation of ABO blood grouping in gel techniques.

Search-Cyte® 0.8%,

Search-Cyte® Plus 0.8%,

Search-Cyte® TCS 0.8%

For the detection of unexpected antibodies in gel techniques.

Search-Cyte® Pool 0.8%

For the detection of unexpected antibodies in gel techniques.

Data-Cyte® Plus 0.8%

For the identification of unexpected antibodies in gel techniques.

Please submit all final printed labeling at the time of use and include implementation information on Form FDA 356h. Please provide a PDF electronic copy as well as three original paper copies for circulars and other labels.

Two draft copies of the proposed introductory promotional labeling may be voluntarily submitted for advisory comment with a Form FDA 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448.

We will include information contained in the above-referenced supplement in your biologics license application file.

Sincerely yours,

Richard J. Davey, MD
Director
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics
Evaluation and Research

Enclosure