CLIA Waiver definition

CLIA Waiver means waiver by the United States Food and Drug Administration, or any successor agency thereof (the “FDA”), to the requirements of the Clinical Lab Improvement Amendments of 1988. *** Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with the Commission.
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CLIA Waiver means the receipt of a certificate from the U.S. Center for Disease Control confirming the waived status of the NTx/Digital Response Device for POC applications pursuant to the Clinical Laboratory Improvement Amendments of 1988 ('CLIA').
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CLIA Waiver means the receipt of a certificate from either the U.S. Center for Disease Control or the FDA confirming the waived status of the NTx/DRx Device for POC applications pursuant to the Clinical Laboratory Improvement Amendments of 1988 ("CLIA").
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Examples of CLIA Waiver in a sentence

  • The Clinical Laboratory Improvement Amendment (CLIA) of 1988 requires laboratories and other facilities that test human specimens to obtain either a CLIA Waiver or CLIA Certificate in order to obtain reimbursement from the Medicare and Medicaid (AHCCCS) programs.

  • Industry will inform FDA that it plans to submit a dual submission (510(k) and CLIA Waiver application) during the Pre-Submission process.

  • During the pre-submission process, if the applicant informs FDA that it plans to submit a dual submission (510(k) and CLIA Waiver application), FDA will issue a decision for 90% of such applications within 210 FDA days.

  • FDA Days are those calendar days when a submission is considered to be under review at the Agency for submissions that have been accepted (510(k) or De Novo request), filed (PMA) or submitted (CLIA Waiver by application).

  • CLIA Waiver by Application Submissions: Decisions for CLIA Waiver by Application Submissions are approval, withdrawal, and denial.

  • A sponsor or applicant may request a Submission Issue Meeting to discuss deficiencies identified during premarket review of a 510(k), de novo, IDE, HDE, PMA, IND or BLA application or CLIA Waiver by Application, including associated amendments or supplements, whether these deficiencies were communicated in writing (e.g., additional information, major deficiency, or not approvable letter) or through email, telephone, or fax (e.g., telephone hold).

  • If the phase and amplitude of this torque are chosen correctly, this torque compensates all dissipation channels including the coupling of the magnons to the cavity photons, and the avoided level crossing of the CMP coalesces.

  • To obtain a CLIA Certificate of Waiver, organizations must complete an application (CLIA Waiver Application Form) and upon approval will be invoiced a $180 fee.

  • To assess the performance of the Click device for detection of CT, NG, and TV in self-collected vaginal specimens as compared to PIS determined by three approved comparator assays using vaginal specimens collected by a qualified HCP in support of obtaining FDA clearance and a Clinical Laboratory Improvement Amendments (CLIA) Waiver.

  • Applicant means a person who makes any of the following submissions to FDA: • an application for premarket approval under section 515 of the Federal Food, Drug, and Cosmetic Act (FD&C Act);• a premarket notification under section 510(k) of the FD&C Act;• an application for investigational device exemption under section 520(g) of the FD&C Act;• a Pre-Submission;• a De Novo classification request (De Novo request) under section 513(f)(2) of the FD&C Act;• a CLIA Waiver by application.

Related to CLIA Waiver

  • Express Waiver I desire to expressly waive any claim of confidentiality as to any and all information contained within our response to the competitive procurement process (e.g. RFP, CSP, Bid, RFQ, etc.) by completing the following and submitting this sheet with our response to Education Service Center Region 8 and TIPS. Signature Date

  • Waiver Agreement means an agreement between

  • bond waiver means an agreement with a developer for the provision of a form of financial security as a substitute for a bond; "calendar year" means the twelve months ending with 31st December;

  • Waiver means the approval by the Board of a material departure from a provision of this Code. An “implicit waiver” means the Company’s failure to take action within a reasonable period of time regarding a material departure from a provision of this Code that has been made known to an executive officer of the Company. An “amendment” means any amendment to this Code other than minor technical, administrative or other non-substantive amendments hereto.

  • General Release has the meaning stated in Section 6.03.

  • Waiver and Release means the Waiver and Release attached hereto as Exhibit A.

  • Reaffirmation Agreement means that certain Reaffirmation Agreement, dated as of the date hereof, between the Loan Parties and the Administrative Agent, for the benefit of the Administrative Agent and the Lenders and the other holders of the Secured Obligations.

  • Forbearance Agreement means the forbearance agreement entered into by Granite Co. prior to the implementation of the 2011 Arrangement.

  • Release Agreement means an agreement, substantially in a form approved by the Company, pursuant to which Executive releases all current or future claims, known or unknown, arising on or before the date of the release against the Company, its subsidiaries and its officers.

  • Landlord Waiver means a letter in form and substance reasonably acceptable to the Administrative Agent and executed by a landlord in respect of Inventory of a Loan Party located at any leased premises of a Loan Party pursuant to which such landlord, among other things, waives or subordinates on terms and conditions reasonably acceptable to the Administrative Agent any Lien such landlord may have in respect of such Inventory.

  • Lien Waiver Agreement means an agreement which is executed in favor of Agent by a Person who owns or occupies premises at which any Collateral may be located from time to time and by which such Person shall waive any Lien that such Person may ever have with respect to any of the Collateral and shall authorize Agent from time to time to enter upon the premises to inspect or remove the Collateral from such premises or to use such premises to store or dispose of such Inventory.

  • Noncompetition Agreement has the meaning stated in Section 2.1.

  • Amendment Agreement shall have the meaning assigned to such term in the recitals hereto.

  • Covenant not to compete means an agreement:

  • Waiver or variance means action by the board which suspends in whole or in part the requirements or provisions of a rule as applied to an identified person on the basis of the particular circumstances of that person. For simplicity, the term “waiver” shall include both a “waiver” and a “variance.”

  • Consent Agreement means this Consent Agreement, duly signed and concluded between the Commission and the Respondent, as contemplated in section 40(1) of the Act.

  • Release of Claims means the Release of Claims in substantially the same form attached hereto as Exhibit A (as the same may be revised from time to time by the Company upon the advice of counsel).

  • Exclusivity Agreement , in relation to land, means an agreement, by the owner or a lessee of the land, not to permit any person (other than the persons identified in the agreement) to construct a solar pv station on the land;”;

  • Diversion agreement means a mechanism designed to hold a child accountable for his or her behavior and, if appropriate, securing services to serve the best interest of the child and to provide redress for that behavior without court action and without the creation of a formal court record;

  • Standstill Agreement shall have the meaning set forth in Section 6.03.

  • Employment Agreement has the meaning specified in the recitals to this Agreement.

  • Non-Competition Agreement has the meaning set forth in Section 2.1 of this Agreement.

  • Reservation agreement means a written contract entered into between MBOH and the taxpayer to provide for a Reservation and setting forth the terms and conditions under which the taxpayer may obtain a Carryover Commitment or Final Allocation.

  • Severance Agreement means the Key Executive Severance Agreement, dated as of the date hereof, between the parties, as it may be amended from time to time, that provides for certain benefits related to termination of the Executive’s employment that are unrelated to a Change of Control.

  • Spousal Consent has the meaning set forth in Section 7.19.

  • Restrictive Covenant Agreement means any agreement, and any attachments or schedules thereto, entered into by and between the Participant and the Partnership or its Affiliates, pursuant to which the Participant has agreed, among other things, to certain restrictions relating to non-competition (if applicable), non-solicitation and/or confidentiality, in order to protect the business of the Partnership and its Affiliates.