CE-IVD definition

CE-IVD means approved CE Marking according to the Requirements of European Directive 98/79/EC of the European Parliament and of the council of 27 October 1998 on in vitro diagnostic medical devices (IVDD) or its successor Directive.
CE-IVD means in vitro diagnostic CE marked products" CE mark " or "CE marked"means a certification mark that indicates conformity with health,safety, and environmental protection standards for products sold within the European Economic Area"certificated form" or "in certificated form"means recorded on the relevant register of the share or securityconcerned as being held in certificated form (that is not in CREST)" Company " or " Yourgene " or "Yourgene Health"means Yourgene Health plc, a company registered in England and Wales with registration number 03971582"Conditions"means the conditions set out in clause 2 of the PlacingAgreement" Consideration Shares"means the new Ordinary Shares to be issued by the Company tothe shareholders of Elucigene pursuant to the Acquisition Agreement "CREST"means the computer based system and procedures which enabletitle to securities to be evidenced and transferred without a written instrument, administered by Euroclear UK & Ireland Limited" C R E S TRegulations"means the Uncertificated Securities Regulations 2001 (SI 2001No. 3755)"Directors"means the directors of the Company as at the date of thisAnnouncement"Elucigene"means Delta Diagnostics (UK) Limited, a company registered inEngland and Wales with registration number 8696299, trading as Elucigene Diagnostics" Existing Share Capital"means the 458,999,688 Ordinary Shares in issue as at the dateof this Announcement"Enlarged Group"means the Group (including Elucigene and its subsidiaryundertakings) following completion of the Acquistion" Enlarged Share Capital"means the Existing Share Capital as enlarged by the issue of theFundraise Shares and the Consideration Shares"EPS"means earnings per share"FCA"means the Financial Conduct Authority"FSMA"means the Financial Services and Markets Act 2000 (asamended)"Fundraise"means the Placing and the Subscription"Fundraise Shares"means the Placing Shares and the Subscription Shares together"Group" means the Company and its subsidiary undertakings" Illumina License Agreement"means the license and supply agreement dated 14 September2018 between the Company and Illumina, Inc."IVD"means in vitro diagnostic, being the in vitro examination ofspecimens derived from the human body to provide information for screening, diagnosis or treatment monitoring purposes" London Stock Exchange" or "LSE"means London Stock Exchange plc"M&A"means mergers and acquisitions"MAR"means Regulation (EU) No. 596/2014 on market abuse andapplicable implementing legislation...

Examples of CE-IVD in a sentence

  • This CE/IVD is compliant to Regulation (EU) 2017/746 only if used as described in these instructions for use within the scope of the intended purpose.

  • The hTERT test is registered as an IVD medical device in the US (Class 1 IVD), Europe (CE-IVD marking), Australia (Class I IVD) and South Korea (Class II IVD) for use as a clinical diagnostic by pathology laboratories for the detection of hTERT in cytopathology samples.

  • Comparison of Amsel criteria, Nugent score, culture and two CE-IVD marked quantitative real-time PCRs with microbiota analysis for the diagnosis of bacterial vaginosis.

  • Genetic Signatures was pleased to announce in January that CE-IVD registration had been received for the EasyScreenTM STI Genital Pathogen Detection Kit.

  • Further evaluation to identify the potential mechanism of resistance may be performed.The use of FDA-cleared or CE-IVD certified rapid diagnostic tests to identify S.

  • Eurofins has multiple CE-IVD marked immunoassays to detect SARS-CoV-2 antibodies with very high sensitivity and specificity.

  • This Viracor Eurofins kit was the basis from which the Eurofins GSD NovaPrime® CE-IVD marked RT-PCR kit was developed in May, a prime example of Eurofins’ ability to quickly transfer know-how and intellectual property across its laboratory network to offer its most innovative tests and kits to clients across the world.

  • These contrived samples prepared and blinded from the investigator fortesting with exsig™ COVID-19 Direct (CE-IVD) on the q16 qPCR instrument.

  • Israel recognizes several international medical device certifications including the European CE-IVD mark.

  • The Ultra assay is expected to achieve CE-IVD certification in April 2017.

Related to CE-IVD

  • Multiple tomogram system means a computed tomography X-ray system which obtains X-ray transmission data simultaneously during a single scan to produce more than one tomogram.

  • own-source revenue means adjusted underlying revenue other than revenue that is not under the control of council (including government grants)

  • Diagnostic x-ray system means an x-ray system designed for irradiation of any part of the human or animal body for the purpose of diagnosis or visualization.

  • Single tomogram system means a CT x-ray system which obtains x-ray transmission data during a scan to produce a single tomogram.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Collaborative pharmacy practice means a practice of pharmacy whereby one or

  • Collaborative pharmacy practice agreement means a written and signed

  • Product Backlog means a list of those Stories that do not form part of the current Sprint Plan at that time and which are to form the subject of a future Sprint, either in the current Release at that time or a subsequent Release;

  • Biomarker means a parameter or characteristic in a patient or Patient Sample, the measurement of which is useful (a) for purposes of selecting appropriate therapies or patient populations or monitoring disease susceptibility, severity or state, or monitoring therapies for such patient and/or (b) for predicting the outcome of a particular treatment of such patient.

  • FTE means full-time equated.

  • Routine Patient Costs means all health care services that are otherwise covered under the Group Contract for the treatment of cancer or other Life-threatening Condition that is typically covered for a patient who is not enrolled in an Approved Clinical Trial.

  • Medical evaluation means the process of assessing an individual's health status that includes a medical history and a physical examination of an individual conducted by a licensed medical practitioner operating within the scope of his license.

  • Third Party Payments means the payment made through instruments issued from an account other than that of the beneficiary investor mentioned in the application form. However, in case of payments from a joint bank account, the first named applicant/investor has to be one of the joint holders of the bank account from which payment is made.

  • Quantitative fit test or "QNFT" means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.

  • Disaster recovery project means a project located on property

  • Program Costs means all necessary and incidental costs of providing program services.

  • Performance Indicators means the indicators for Project monitoring and evaluation set forth in the Operational Manual.

  • Development Plans means a coherent set of operations defined and financed exclusively by the OCTs in the framework of their own policies and strategies of development, and those agreed upon between an OCT and the Member State to which it is linked;

  • Licensed Nurse means an Oregon licensed practical or registered nurse.

  • Category 4 Data is data that is confidential and requires special handling due to statutes or regulations that require especially strict protection of the data and from which especially serious consequences may arise in the event of any compromise of such data. Data classified as Category 4 includes but is not limited to data protected by: the Health Insurance Portability and Accountability Act (HIPAA), Pub. L. 104-191 as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH), 45 CFR Parts 160 and 164; the Family Educational Rights and Privacy Act (FERPA), 20 U.S.C. §1232g; 34 CFR Part 99; Internal Revenue Service Publication 1075 (xxxxx://xxx.xxx.xxx/pub/irs-pdf/p1075.pdf); Substance Abuse and Mental Health Services Administration regulations on Confidentiality of Alcohol and Drug Abuse Patient Records, 42 CFR Part 2; and/or Criminal Justice Information Services, 28 CFR Part 20.

  • Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

  • Third Party Payors means Medicare, Medicaid, CHAMPUS, Blue Cross and/or Blue Shield, private insurers and any other Person which presently or in the future maintains Third Party Payor Programs.

  • State average current expense appropriations per student means the most

  • Development Expenses means, with respect to SAIL Developments as well as HOME Developments when the HOME Development is also at least partially financed with a MMRB Loan (as defined in rule Chapter 67-21, F.A.C.), usual and customary operating and financial costs, such as the compliance monitoring fee, the financial monitoring fee, replacement reserves, the servicing fee and the debt service reserves. As it relates to SAIL Developments as well as HOME Developments when the HOME Development is also at least partially financed with a MMRB Loan (as defined in rule Chapter 67-21, F.A.C.) and to the application of Development Cash Flow described in subsections 67-48.010(5) and (6), F.A.C., as it relates to SAIL Developments or in paragraph 67-48.020(3)(b), F.A.C., as it relates to HOME Developments, the term includes only those expenses disclosed in the operating pro forma on an annual basis included in the final credit underwriting report, as approved by the Board, and maximum of 20 percent Developer Fee per year.

  • Development Costs means costs incurred to obtain access to reserves and to provide facilities for extracting, treating, gathering and storing the oil and gas from reserves. More specifically, development costs, including applicable operating costs of support equipment and facilities and other costs of development activities, are costs incurred to:

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.