Diagnostics Field

Diagnostics Field. Means all sampling methods and applications for the [CONFIDENTIAL TREATMENT REQUESTED] in connection with the diagnosis and treatment of any disease or condition in animals and humans, including but not limited to diabetes and complications of diabetes. 1

Diagnostics Field. In-vitro products, devices, reagents, components, systems, applications, software and/or assays for clinical use, including without limitation diagnostic and prognostic tests, in each case that may require a premarket clearance or approval, including a 510k, ASR (provided that Catalyst may not sell an ASR product that is identical in formulation to one of Agilent's cataolog products), or PMA, from the Federal Food and Drug Administration or a foreign equivalent governing body, or that is... manufactured under and in compliance with Quality Systems Regulations governing the manufacture of in-vitro diagnostics and/or devices, before the same may enter the stream of commerce, but excluding the fields of urinalysis, autoimmune and allergy testing. View More