Approval History, Letters, Reviews, and Related Documents - Seraclone Anti-S (Monoclonal)

Proper Name: Blood Grouping Reagent Anti-S (Monoclonal)
Tradename: Seraclone
Manufacturer: Biotest Medical Diagnostics GmbH
STN: 125216/0
Approval Date: August 14, 2008

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Approval information/letter/labeling

Memorandum/Reviews

• Summary Basis for Regulatory Action
• Meeting with Biotest Memo
• Review Memo: Biotest AG’s Blood Grouping Reagents Anti-S (Monoclonal) and Anti-Jk^b (Monoclonal) (12/11/2007)
• Review Memo: Biotest AG's Blood Grouping Reagents Anti-S (Monoclonal) and Anti-Jk^b (Monoclonal) (07/07/2008)
• Request to Waive STN 125216/0 from Referral to Blood Products Advisory Committee
• Recommendation to Waive Pre-Approval Inspection Memo
• Categorical Exclusion under 21 CFR 25.31(c)
• Review Memo: Biotest AG’s Blood Grouping Reagents Anti-S (Monoclonal) and Anti-Jkb (Monoclonal) (12/19/2006) (PDF - 98 KB)
• Review Memorandum – Biotest AG, License Number 1702 (5/30/2007) (PDF - 96 KB)
• Review Memorandum – Biotest AG, License Number 1702 (6/30/2008)
• Review Memorandum
• Review of BLA - Blood Grouping Reagents, July 27, 2007 (PDF -101 KB)
• Review of BLA - Blood Grouping Reagents, January 31, 2008 (PDF - 44 KB) 
• Review Memorandum - Blood Grouping Reagents, December 19, 2006 (PDF - 104 KB)

Administrative Documents

• Officer/Employee List

Correspondence

• 01/14/2008 Telecon
• 01/18/2008 Telecon
• 08/05/2008 Telecon
• 07/27/2007 Letter (PDF - 55 KB)
• 01/31/2008 Letter (PDF - 66 KB)
• Letter