Product Approval Information
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-Jkb (Monoclonal) (12/11/2007)
- Review Memo: Biotest AG's Blood Grouping Reagents Anti-S (Monoclonal) and Anti-Jkb (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)
Administrative Documents
Correspondence
- 01/14/2008 Te lecon
- 01/18/2008 Telecon
- 08/05/2008 Telecon
- 07/27/2007 Letter (PDF - 55 KB)
- 01/31/2008 Letter (PDF - 66 KB)
- Letter