Product Approval Information
Proper Name: Blood Grouping Reagent Anti-S (Monoclonal)
Tradename: Seraclone
Manufacturer: Biotest Medical Diagnostics GmbH
Package Insert (PDF - 137 KB) - Approved: August 14, 2008
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Date: August 14, 2008
Indication: For the determination of the blood group antigens on red blood cells using the tube test
August 14, 2008 Approval Letter
Summary Basis for Regulatory Action
Approval History, Letters, Reviews, and Related Documents