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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Biotestcell and Erytypecell

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