Diagnostic Products means products or services that (i) are used in the diagnosis, prognosis, screening or detection of disease in humans, and (ii) which employ, or are in any way produced or manufactured by, or discovered, identified, developed or otherwise arise out of any research involving, the practice or use of the inventions of the Licensed Patents other than the Licensed Patents listed in B-3, or that would otherwise constitute infringement of any claims of the Licensed Patents other than the Licensed Patents listed in B-3. Diagnostic Products does not include B-3 Diagnostic Products.
Diagnostic Products means an assay provided as a product or service performed on a human tissue or other human biological sample containing nucleic acids or proteins that are collectively intended to establish or identify an association between the presence or absence of such nucleic acids or proteins and:
Diagnostic Products means any device, product, process, substance, composition or service intended to predict, detect, identify or monitor a disease or determine the presence of a pathologic condition in humans.
Examples of Diagnostic Products in a sentence
Commer- cially available RIA kits were used to measure aldosterone (Diagnostic Products Corporation, Los Angeles, CA, USA) and cortisol (Immunotech, Beckman Coulter, Marseille, France).
In addition, as of January 1, 2004, the Diagnostic Products segment was reorganized into four separate divisions.
For segment reporting purposes, these divisions are aggregated and reported as the Diagnostic Products segment.
In March 2011, the Global Fund established the Global Fund Quality Assurance Policy for Diagnostic Products (“the QA Policy”).
FDA, CDRH/CBER, Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only, Guidance, November 25, 2013, http://www.fda.gov/downloads/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/UCM376118.pdf.
More Definitions of Diagnostic Products
Diagnostic Products means products that contain a Collaboration Antibody for the diagnosis or prognosis of any human disease. For purposes of this Agreement, two products that satisfy the foregoing definition of “Diagnostic Product” will be deemed to be different Diagnostic Products if they contain different Collaboration Antibodies.
Diagnostic Products means any diagnostic test incorporating an Assay or the BSP Array, either alone or in combination with one or more other diagnostic tests, which has been approved, to the extent approval is necessary, by a Regulatory Authority (whether for a Clinical Trial or for commercial sale) for diagnosing or detecting one or more separate and distinct diseases or medical conditions in humans.
Diagnostic Products as used herein shall mean products that are subject to regulatory approval requirements under applicable law, regulations or policies of regulatory agencies (i.e., PMA or 510(k), or foreign equivalent) and are useful for chemical or biochemical analysis of human samples in a health care setting, such as a reference laboratory, hospital laboratory, hospital, clinic, doctor's office or at home, and veterinary products utilizing similar technology to the above products. HP will not be prohibited from selling Collaboration Products designed for research, development, analytical or manufacturing use to such customers, provided all products are labeled in accordance with Section 6.4. Caliper will not be prohibited from introducing products designed for diagnostic use by such customers while Caliper is in the course of pursuing FDA approval on such a product, or from transferring such rights to any Third Party.
Diagnostic Products means any product which is offered, or is reasonably intended by MPMx to be offered, for sale to third parties (e.g., testing laboratories, physicians, hospitals and patients) pursuant to an arms-length transaction, in the form of a device, compound or kit, that is used to identify patients having a particular disease or predisposition to a disease and/or to monitor the course, prognosis or recurrence of such disease in such patients.
Diagnostic Products shall have the meaning set forth in Section 2.2(f).
Diagnostic Products means products that are subject to regulatory approval requirements under applicable law, regulations or policies or regulatory agencies (i.e., PMA or 510(k), or foreign equivalent) or are used for chemical or biochemical analysis of human samples in a health care setting, such as a reference laboratory, hospital laboratory, hospital, clinic, doctor's office or at home, in each case where a patient or his insurance company pays for such analysis, and veterinary products utilizing similar technology in a similar setting to the above products.
Diagnostic Products means products which are intended to monitor the course of disease or therapy in humans, predict, detect or identify a disease in humans, or determine the outcome of a pathological condition in humans.