Product Approval Information

Proper Name: Blood Grouping Reagent Anti-Fy^a (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-Fy^a (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-Fy^a (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

• Administrative Bundled File Biotest AG (LIC #1702):
• Officer/Employee List

Correspondence

• 8/5/2008 Telecon
• Letter Regarding Review of Amendments
• 7/27/2007 Letter (PDF - 148 KB)
• 1/31/2008 Letter (PDF 92 KB)

CBER Information

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