Product Approval Information
Proper Name: Blood Grouping Reagent Anti-s (Monoclonal)
Tradename: Seraclone
Manufacturer: Biotest Medical Diagnostics GmbH
STN: 125214/0
Approval Date: August 14, 2008
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Approval information/letter/labeling
Memorandum/Reviews
- Review Memo - Biotest AG, license number 1702. Response (submitted November 30, 2007) to our CR letter (issued July 30, 2007)
- Review Memo - Biotest AG’s Blood Grouping Reagents
- Review Memo and Recommendation - Biotest AG’s Blood Grouping Reagents Anti-Fya (Monoclonal) and Anti-s (Monoclonal)
- Review Letter - Amendments to BLA
- Request to Waive Memo - STN 125214/0 from referral to Blood Products Advisory Committee
- Recommend Memo - Recommendation to Waive Pre-Approval Inspection
- Review Memo - Categorical Exclusion under 21 CFR 25.31(c)
- Review Letter - Submissions dated November 30, 2007 ( PDF- 104 KB)
- Review Memo - Original Application / Prior Approval Supplement (PDF 135 KB)
- Review Memo - Manufacturing Summary (PDF 100 KB)
- Review Letter - Deficiencies in CMC/CLINCAL/STATISTICS/LABELING/OTHER (PDF 94 KB)
Administrative Documents
Correspondence