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Office of In Vitro Diagnostics and Radiological Health
Results: 5

#	Item
1	FDA Update Office of In Vitro Diagnostics and Radiological Health (OIR) Alberto Gutierrez, Ph.D. CLIAC November 5, 2014 Add to Reading List Source URL: ftp.cdc.gov Language: English - Date: 2014-11-04 20:45:46 Clinical research Center for Devices and Radiological Health Premarket approval Okushiri Airport Cretan lyra Food and Drug Administration Medicine Pharmaceutical sciences
2	Regulation of Flow Cytometric In Vitro Diagnostic Devices Kevin Maher, Ph.D., DABMLI Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Add to Reading List Source URL: www.fda.gov Language: English Health Premarket approval Medical device Center for Devices and Radiological Health Pre-clinical development Federal Food Drug and Cosmetic Act Title 21 of the Code of Federal Regulations New Drug Application Medicine Food and Drug Administration Technology
3	Analytical Validation and Points for Discussion Julia Tait Lathrop, PhD Immunology and Hematology Branch Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Add to Reading List Source URL: www.fda.gov Language: English Validity Science Clinical research Quality Validation Immunologic tests Proteomics Immunoassay Biomarker Medicine Pharmaceutical industry Biology
4	Strip Test, Isoniazid Classification Panel Meeting April 25, 2013 Christine King, MS, MT (ASCP) Scientific Reviewer—Chemistry and Toxicology Devices Office of In-vitro Diagnostics and Radiological Health Add to Reading List Source URL: www.fda.gov Language: English Isoniazid Latent tuberculosis Hepatitis Drug-induced lupus erythematosus Sideroblastic anemia Anion gap Tuberculosis treatment Medicine Tuberculosis Health
5	Responsible Office/Division: Office of the Device Evaluation (ODE) Office of In Vitro Diagnostics and Radiological Health (OIR) Process Owner ODE Clinical Trials Director/OIR Chief Medical Officer Add to Reading List Source URL: www.fda.gov Language: English Research Food and Drug Administration Pharmaceutical industry Pharmacology Investigational Device Exemption Center for Devices and Radiological Health Clinical trial Medical device IDE Medicine Clinical research Pharmaceutical sciences