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215 results
  1. Appendices - Lyme disease: diagnosis and management - NCBI Bookshelf 
    https://www.ncbi.nlm.nih.gov/books/NBK550402
    ... ELISA C6 (IgA) Figure 18 ELFA Figure 19 CLIA (IgM) Figure 20 CLIA (IgG) Figure 21 CLIA (IgM/IgG) Figure 22 Western blot/Immunoblot (IgM) ... 34 ELISA C6 Figure 35 ELFA Figure 36 CLIA (IgM/IgG) Figure 37 Western blot/Immunoblot (IgM/) ...
  2. NLM Digital Collections - Administrative procedures for CLIA categorization : guidance for industry and Food and Drug ... 
    Publication: Silver Spring, MD : Center for Devices and Radiological Health, October 2, 2017
    resource.nlm.nih.gov/101719834
    Administrative procedures for CLIA categorization : guidance for industry and Food and Drug Administration staff ... Administrative procedures for CLIA categorization : guidance for industry and Food and Drug Administration staff Guidance for industry United States. Department of Health and ...
  3. NLM Digital Collections - Recommendations for clinical laboratory improvement amendments of 1988 (CLIA) waiver ... 
    Publication: Silver Spring, MD : Center for Devices and Radiological Health, February 26, 2020
    resource.nlm.nih.gov/101772617
    Recommendations for clinical laboratory improvement amendments of 1988 (CLIA) waiver applications for manufacturers of in vitro diagnostic ... under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and are thus eligible for waiver categorization (69 ...
  4. NLM Digital Collections - Recommendations for dual 510(k) and CLIA waiver by application studies : guidance for ... 
    Publication: Silver Spring, MD : Center for Devices and Radiological Health, February 26, 2020
    resource.nlm.nih.gov/101772620
    Recommendations for dual 510(k) and CLIA waiver by application studies : guidance for industry and Food and Drug Administration staff ... Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application pathway. It describes study designs ...
  5. Genetics of Kidney Cancer (Renal Cell Cancer) (PDQ®) - PDQ Cancer Information Summaries - NCBI Bookshelf 
    https://www.ncbi.nlm.nih.gov/books/NBK169222
    ... Genetic tests performed in Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories are available for the genes associated ... available and performed by Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories. FH currently is the only gene ...
  6. How can I be sure a genetic test is valid and useful?: MedlinePlus Genetics 
    https://medlineplus.gov/genetics/understanding/testing/validtest
    ... regulatory standards called the Clinical Laboratory Improvement Amendments (CLIA) or even stricter state requirements. CLIA standards cover how tests are performed, the qualifications ...
  7. Results - Technology Assessment of Molecular Pathology Testing for the Estimation of Prognosis for Common Cancers - ... 
    https://www.ncbi.nlm.nih.gov/books/NBK285416
    ... The CAP sends proficiency test EGFR unknowns to CLIA-approved US clinical laboratories or International clinical laboratories ... carcinoma. CAP sends proficiency test KRAS unknowns to CLIA-approved US clinical laboratories or International clinical laboratories ...
  8. NLM Digital Collections - A catalogue of scientific and technical periodicals, 1665-1895 : together with chronological .... 
    Publication: City of Washington : Smithsonian Institution, 1897
    resource.nlm.nih.gov/58810410R
    ... Ws: Wsp : Yc : Yp 627. BH : Bap : CH : CliA : Chc : I : NY : 0Q : PA : Pp : WM : W° : ... BA : BH : Bp : Bap : Bg : Br : CH : Cz : CliA : CkN : Cinp : I : LA : Lo : MH : Mip : NB : ... Lr : WA : IVs: Wt 1587. BH : Bus : Cz : CliA : I : LA : Ne : NY : PA : WA : Wp : Ws : ...
  9. Results - Addressing Challenges in Genetic Test Evaluation - NCBI Bookshelf 
    https://www.ncbi.nlm.nih.gov/books/NBK56754
    ... for analytic validity : The Clinical Laboratories Improvement Amendments ( CLIA ) program administered by CMS State-based regulatory programs, ... tests on humans in the U.S. through CLIA and has responsibility for implementing the CLIA Program. ...
  10. Challenges in and Principles for Conducting Systematic Reviews of Genetic Tests Used as Predictive Indicators - Methods ... 
    https://www.ncbi.nlm.nih.gov/books/NBK98231
    ... Medicaid Services (CMS) under Clinical Laboratory Improvement Act (CLIA) regulations for clinical laboratories. CLIA does not require clinical validation and many LDTs ...
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