definiens: means any hardware, software, device, platform .or any combination or component thereof, including any uniquely associated accessories and consumables, . which Js related to the automation of in vitro amplification, ' detection, quantification, or . sequencing of a nucleic acid in or from a human biological sample for the purpose of : ( i ) diagnosing, detecting or monitoring any disease, state ; condition, trait or · ' characteristic of a human being for medical management ; ( ii ) exercising quality assurance and quality control testing of human blood or plasma from which biological therapeutic agents may be derived for resale ; ( iii ) [ unless excluded by decision pursuant to Section 2.4 . screening human blood or blood products for transfusion ) ; or ( iv ) screening human organs, tissues or cells for transplantation . The term .excludes ( a ) Reagents and kits containing Reagents, ( b ) instruments for the preparation of human biological samples containing nucleic acids, ( c ) instruments which are the subject of supply arrangements existing as of the Effective Date between a Party and a Third Party, including modifications, amendments or extensions to such arrangements, provided such arrangements are not inconsistent with such Party 's obligations under this Agreement, and ( d ) instruments which are manufactured by [COMPANY] as of the Effective Date and in any subsequent modified form, provided such instruments are not Competing Products