Seraclone Blood Grouping Reagents and Anti-Human Globulin Reagents

Proper Name: Blood Grouping Reagents and Anti-Human Globulin reagents
Tradename: Seraclone
Manufacturer: Biotest Medical Diagnostics GmbH

Package Inserts - Approved: August 14, 2008

• Anti-P1 (P1) (PDF - 69 KB)
• Anti-Jk^a (JK1); Anti-Jk^b (JK2) (PDF - 73 KB)
• Anti-A (ABO1); Anti-B (ABO2); Anti-A,B (ABO3) (PDF - 83 KB)
• Anti-D (RH1) (PDF - 82 KB)
• Anti-D (RH1) Blend (PDF - 89 KB)
• Anti-M (MNS1); Anti-N (MNS2) (PDF - 76 KB)
• Anti-C (RH2); Anti-c (RH4); Anti-E (RH3); Anti-e (RH5) (PDF - 87 KB)
• Anti-K (KEL1) (PDF - 73 KB)
• Anti-k (KEL2) (PDF - 83 KB)
• Anti-Le^a (LE1) (PDF - 79 KB)
• Anti-IgG (PDF - 74 KB)
• Anti-IgG, -C3d; Polyspecific (PDF - 94 KB)

Date: September 23, 2008
Indication: Correction letter to correct the "dating period" in the August 14, 2008 biologics license application Approval Letter for STN BL 125229/0 Blood Grouping Reagent Anti-e (Monoclonal).
September 23, 2008 - Corrected Approval Letter

Date: August 14, 2008
Indication: For the determination of the blood group antigens on red blood cells and detecting in vivo and /or in vitro coating of red blood cells using the tube test
August 14, 2008 Approval Letter