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Additional Manufacturer Narrative

HUMAN PLASMA IS USED FOR THE PREPARATION OF STA COAG CONTROL N, CAT. 00676, LOT # 042736. FDA-APPROVED METHODS ARE USED TO TEST THE HUMAN PLASMA FOR ANTIBODIES TO HIV 1, HIV 2, AND HCV, AND FOR HEPATITIS B SURFACE ANTIGEN. ONLY PLASMAS NEGATIVE FOR ALL MARKERS ARE USED FOR MFG THIS PROD. THE FOLLOWING WARNING IS MENTIONED IN THE PACKAGE INSERT OF THIS REAGENT: "THE REAGENTS PROVIDED IN THIS KIT CONTAIN MATERIALS OF HUMAN AND/OR ANIMAL ORIGIN. WHENEVER HUMAN PLASMA IS REQUIRED FOR THE PREPARATION OF THESE REAGENTS, FDA-APPROVED METHODS ARE USED TO TEST THE PLASMA FOR THE ANTIBODIES TO HIV 1, HIV 2, AND HCV, AND FOR HEPATITIS B SURFACE ANTIGEN AND RESULTS ARE FOUND TO BE NEGATIVE. HOWEVER, NO TEST METHOD CAN OFFER COMPLETE ASSURANCE THAT INFECTIOUS AGENTS ARE ABSENT. THEREFORE, USERS OF REAGENTS OF THESE TYPES MUST EXERCISE EXTREME CARE IN FULL COMPLIANCE WITH REGULATORY SAFETY PRECAUTIONS IN THE MANIPULATION OF THESE BIOLOGICAL MATERIALS AS IF THEY WERE INFECTIOUS." IT IS INDICATED IN THE PACKAGE INSERT OF THIS REAGENT SECTION 3/ KIT REAGENTS THE FOLLOWING : "REAGENT 1: STA COAG CONTROL N, CITRATED NORMAL HUMAN PLASMA, FREEZE DRIED."