Product Approval Information
Proper Name: Blood Grouping Reagent, Anti-A (Murine Monoclonal); Anti-B (Murine Monoclonal); Anti-A,B (Murine Monoclonal Blend); Anti-D (Monoclonal) (IgM)
Tradename: Component of Erytype S
Manufacturer: Biotest AG, License #1702
Package Insert (PDF - 152 KB) - July, 2005
Date: July 26, 2005
Indication: To perform a single ABO Grouping and D Typing or label confirmation for donor ABO Grouping and/or D Typing (for exclusive use on the Tango Automated Analyzer)
July 26, 2005 Approval Letter
November 4, 2005 Corrected Letter