Product Approval Information
Proper Name: Reagent Red Blood Cells; Reagent Red Blood Cells For Use in Automated Systems
Tradename: Biotestcell and Erytypecell
Manufacturer: Biotest Medical Diagnostics GmbH, License #1798
Package Insert - Biotestcell 1 & 2; Biotestcell 3 (PDF - 179 KB) - Approved: August 14, 2008
Package Insert - Erytypecell A1 & B (PDF - 124 KB) - Approved: August 14, 2008
Date: August 14, 2008
Indication: Reagent Red Blood Cells are for use in manual tube testing and Reagent Red Blood Cells For Use in Automated Systems are for use on the TANGO® optimo automated blood grouping and antibody test system
August 14, 2008 Approval Letter