Product Approval Information
Proper Name: OLYMPUS PK System Blood Grouping and Phenotyping Reagents
Manufacturer: DIAGAST, License #1744
Package Insert (Blood Grouping Reagents) (PDF - 169 KB) - Approved: January 10, 2008
Package Insert (Reagent Red Blood Cells) (PDF - 152 KB) - Approved: January 10, 2008
Date: January 10, 2008
Indication: For the in vitro detection and identification of human blood group antigens by direct agglutination
January 10, 2008 Approval Letter
FDA Licenses 14 New Blood-Typing Tests: New tests help assure safe transfusions