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Immunoassay
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291	SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) I. GENERAL INFORMATION Device Generic Name: Quantitative test for determination of [-2]proPSA levels Device Trade Name: Access@ Hybritech@ p2PSA on the Access Immunoassay S Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2012-06-20 14:51:41 Biomarkers Prostate-specific antigen Urology Immunoassay Beckman Medicine Blood tests Immunologic tests
292	QUALITY CONTROL/QUALITY ASSURANCE Add to Reading List Source URL: www.afs-fhs.org Language: English - Date: 2014-08-01 15:46:31 Protocol ELISA Immunoassay Lean laboratory Quality assurance Immunologic tests Laboratories Science
293	64 Guidance for Industry VALIDATION OF ANALYTICAL PROCEDURES: METHODOLOGY FINAL GUIDANCE (October 21, 2010, this guidance document was revised to update contact information, correct broken Add to Reading List Source URL: www.fda.gov. Language: English Measurement Pharmaceutical industry Validity Analytical chemistry Immunologic tests Immunoassay Validation Titration Mass spectrometry Chemistry Science Statistics
294	Interpreting Clinical Laboratory Results from the HIV Diagnostic Testing Algorithm Add to Reading List Source URL: www.health.ny.gov Language: English - Date: 2014-01-21 14:32:22 Microbiology HIV AIDS Immunoassay HIV test HIV/AIDS Health Medicine
295	Avioq HIV-1 Microelisa System Store between 2-8°C. For in vitro diagnostic use. INTENDED USE The Avioq HIV-1 Microelisa System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative Add to Reading List Source URL: www.fda.gov Language: English Hematology Biology Immunologic tests Acronyms Transfusion medicine ELISA Immunoassay HIV Dried blood spot Medicine Health HIV/AIDS
296	Genscreen™ ULTRA HIV Ag-Ab Add to Reading List Source URL: www.fda.gov Language: English Health Acronyms Sexually transmitted diseases and infections Biology ELISA Immunoassay Transfusion medicine HIV AIDS HIV/AIDS Medicine Immunologic tests
297	SUMMARY OF SAFETY AND EFFECTIVENESS DATA Add to Reading List Source URL: www.fda.gov Language: English Medicine Anatomy Immunology Biotechnology Glycoproteins HIV test HIV Immunoassay Monoclonal antibodies HIV/AIDS Biology Immune system
298	® ® Procleix Ultrio Plus Assay For In Vitro Diagnostic Use Add to Reading List Source URL: www.fda.gov Language: English Sexually transmitted diseases and infections Medicine Science Laboratory techniques Virology Immunoassay ELISA Hepatitis B HIV HIV/AIDS Immunologic tests Chemistry
299	..... ViroStat Immunochemicals for Infectious Disease P.O. Box 8522 Portland, Maine 04104 Add to Reading List Source URL: www.virostat-inc.com Language: English - Date: 2009-03-31 15:24:11 Immunology Glycoproteins Medicine Acronyms ELISA Monoclonal antibodies Immunoglobulin G Immunoassay Antibody Biology Immune system Immunologic tests
300	Summary Basis of Approval: Hepatitis C Virus Encoded Antigens (Recombinant c100-3, HCr43, NS5) ABBOTT PRISM® HCV Add to Reading List Source URL: www.fda.gov Language: English Immunoassay Hepatitis C virus NS5 Microbiology HIV Hepatitis C Medicine HIV/AIDS Immunologic tests Biology

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