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Vaccines, Blood & Biologics

August 14, 2008 Approval Letter Supplement - Erytype S

August 14, 2008

Our STNs: Please see table below.

Biotest Medical Diagnostics GmbH
Attention: Dr. Rolf Vornhagen
Industriestrasse 1
D-63303 Dreieich

Dear Dr. Vornhagen:

We have approved your request to supplement your biologics license applications for the products listed below.


Our STN Product Proper Name Cell Line
BL 125097/10 Blood Grouping Reagent, Anti-D (Monoclonal)(IgM)(Formulated for Automated Testing) BS226
BL 125097/10 Blood Grouping Reagent, Anti-D (Monoclonal)(IgM)(Formulated for Automated Testing) BS232
BL 125098/8 Anti-Human Globulin (Formulated for Automated Testing) N/A

Blood Grouping Reagent, Anti-D (Monoclonal)(IgM) (Formulated for Automated Testing) is used as a component of the Erytype® S Rh+K Type plate for Rh typing on the TANGO® optimo automated blood grouping and antibody test system.

Anti-Human Globulin (Formulated for Automated Testing) is used to detect sensitization of red blood cells on the TANGO® optimo system.

Any significance decrease in the reactivity or other changes in these products should be reported promptly to the Center for Biologics Evaluation and Research.

We will include information contained in the above-referenced supplements in your biologics license application files.

Sincerely yours,

/Elizabeth Callaghan/

Elizabeth Callaghan
Acting Director
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics Evaluation & Research


Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

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