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1. ANTIGEN PLUS V7.5 Validation Plan Rowny Systems Inc 1 OF 32

ANTIGEN PLUS V7 5 Validation Plan Rowny Systems Inc 1 OF 32 TITLE ANTIGEN PLUS VALIDATION ee Revised for Version 7 5 EFFECTIVE DATE February 17 2014 1 0 2 0 3 0 4 0 5 0 PRINCIPLE Antigen Plus is a software program designed to store and select red cells for antibody identification testing by phenotype Antigen Plus Version 7 5 is a medical device under the provisions of the FDA 510 k clearance number BK11045 In order to be used as a tool by
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9. ANTIGEN PLUS V7.5 Validation Plan Rowny Systems Inc 1 OF 32

ANTIGEN PLUS V7 5 Validation Plan Rowny Systems Inc 1 OF 32 TITLE ANTIGEN PLUS VALIDATION ee Revised for Version 7 5 EFFECTIVE DATE February 17 2014 1 0 2 0 3 0 4 0 5 0 PRINCIPLE Antigen Plus is a software program designed to store and select red cells for antibody identification testing by phenotype Antigen Plus Version 7 5 is a medical device under the provisions of the FDA 510 k clearance number BK11045 In order to be used as a tool by
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