Product Approval Information

Proper Name: Blood Grouping Reagents and Anti-Human Globulin reagents
Tradename: Seraclone
Manufacturer: Biotest Medical Diagnostics GmbH

Package Inserts - Approved: August 14, 2008

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Date: September 23, 2008
Indication: Correction letter to correct the "dating period" in the August 14, 2008 biologics license application Approval Letter for STN BL 125229/0 Blood Grouping Reagent Anti-e (Monoclonal).
September 23, 2008 - Corrected Approval Letter

Date: August 14, 2008
Indication: For the determination of the blood group antigens on red blood cells and detecting in vivo and /or in vitro coating of red blood cells using the tube test
August 14, 2008 Approval Letter


Updated: September 26, 2008