Product Approval Information

Proper Name: Blood Grouping Reagent
Tradename: Component of Erytype S
Manufacturer: Biotest Medical Diagnostics GmbH, License #1798

Date: August 14, 2008
Indication: Blood Grouping Reagent, Anti-D (Monoclonal)(IgM) (Formulated for Automated Testing) is used as a component of the Erytype® S Rh+K Type plate for Rh typing on the TANGO® optimo automated blood grouping and antibody test system. Anti-Human Globulin (Formulated for Automated Testing) is used to detect sensitization of red blood cells on the TANGO® optimo system.
August 14, 2008 Approval Letter
Package Insert - Erytype S Rh + K Type (PDF - 158 KB) - Approved August 14, 2008
Package Insert - Anti-IgG Solidscreen II (Rabbit) (PDF - 182 KB) - Approved August 14, 2008

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
Package Insert (PDF - 152 KB) - July, 2005

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