Product Approval Information

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

Package Insert - Erytype S Rh + K Type (PDF - 158 KB) - Approved August 14, 2008
Package Insert - Anti-D (RH1) Blend (PDF - 126 KB) - Approved August 14, 2008

Date: August 14, 2008
Indication: For use on the Erytype® S Rh + K Type plate for Rh and Kell typing on the TANGO® optimo automated blood grouping and antibody test system
August 14, 2008 Approval Letter

Date: August 14, 2008 (Supplement Approval)
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

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