Vaccines, Blood & Biologics
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Approval History, Letters, Reviews and Related Documents - Seraclone Anti-Fya (Monoclonal)
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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Memorandum/Reviews
Summary Basis for Regulatory Action - Seraclone Blood Grouping Reagent Anti-Fya (Monoclonal) Review Memorandum: Biotest AG, license number 1702. Response (submitted November 30, 2007) to our CR letter (issued July 30, 2007) - Seraclone Blood Grouping Reagent Anti-Fya (Monoclonal) Review Memorandum and Recommendation: Biotest AG’s Blood Grouping Reagents Anti-Fya (Monoclonal) and Anti-s (Monoclonal) - Seraclone Blood Grouping Reagent Anti-Fya (Monoclonal) Request to waive STN 125212/0 from referral to Blood Products Advisory Committee - Seraclone Blood Grouping Reagent Anti-Fya (Monoclonal) Memorandum: Recommendation to Waive Pre-Approval Inspection - Seraclone Blood Grouping Reagent Anti-Fya (Monoclonal) Memorandum: Meeting with Biotest - Seraclone Blood Grouping Reagent Anti-Fya (Monoclonal) Review Memorandum: Biotest AG’s Blood Grouping Reagents Anti-Fya (Monoclonal) and Anti-s (Monoclonal) - Seraclone Blood Grouping Reagent Anti-Fya (Monoclonal) Review Memorandum - Blood Grouping Reagents (PDF - 226KB)Review Memorandum - Blood Grouping Reagents (Anti-Fy and Anti-S), February 14, 2007 (PDF - 128KB)Review of BLA - Blood Grouping Reagents, July 27, 2007 (PDF - 101KB)Review of BLA - Blood Grouping Reagents, January 31, 2008 (PDF - 44KB)
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