Product Approval Information
Proper Name: Blood Grouping Reagent Anti-Fya (Monoclonal)
Tradename: Seraclone
Manufacturer: Biotest Medical Diagnostics GmbH
STN: 125212/0
Approval Date: August 14, 2008
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Approval information/letter/labeling
Memorandum/Reviews
- Summary Basis For Regulatory Action
- Review Memorandum: Biotest AG, license number 1702. Response (submitted November 30, 2007) to our CR letter (issued July 30, 2007).
- Review Memorandum and Recommendation: Biotest AG’s Blood Grouping Reagents Anti-Fya (Monoclonal) and Anti-s (Monoclonal)
- Request to waive STN 125212/0 from referral to Blood Products Advisory Committee
- Memorandum: Recommendation to Waive Pre-Approval Inspection
- Memorandum: Meeting with Biotest
- Review Memorandum: Biotest AG’s Blood Grouping Reagents Anti-Fya (Monoclonal) and Anti-s (Monoclonal)
- Review Memorandum: Biotest AG, license number 1702. Original Application / Prior Approval Supplement Received on September 22, 2006 With an Action Due Date of July 30, 2007 (PDF - 127 KB).
- Review Memorandum: Biotest AG’s Blood Grouping Reagents Anti-Fya (Monoclonal) and Anti-s (Monoclonal) (PDF - 156 KB)
Administrative Documents
Correspondence