AdvaMedDx Statement for 2013 Clinical Laboratory Public Meeting Open application/pdf - 39.28 kB Date: 07/10/2013 Disease Area: Read more about AdvaMedDx Statement for 2013 Clinical Laboratory Public Meeting
AdvaMedDx CY 2014 Clinical Laboratory Fee Schedule Preliminary Payment Determinations and MAAA Codes Comments Open application/pdf - 1.83 MB Date: 10/25/2013 Disease Area: Read more about AdvaMedDx CY 2014 Clinical Laboratory Fee Schedule Preliminary Payment Determinations and MAAA Codes Comments
AdvaMedDx Statement at CMS Clinical Laboratory Public Meeting July 2014 Open application/pdf - 311.32 kB Date: 07/14/2014 Disease Area: Read more about AdvaMedDx Statement at CMS Clinical Laboratory Public Meeting July 2014
Comments to FDA on Nucleic-Acid Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens Open application/pdf - 1.08 MB Date: 06/18/2012 Disease Area: Read more about Comments to FDA on Nucleic-Acid Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens
Comments to FDA on CLIA Waiver Applications Open application/pdf - 528 kB Date: 11/12/2012 Disease Area: Read more about Comments to FDA on CLIA Waiver Applications
Comments to FDA on Highly Multiplex Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices Open application/pdf - 2.14 MB Date: 02/07/2013 Disease Area: Read more about Comments to FDA on Highly Multiplex Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices
Comments to FDA on Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products Open application/pdf - 846.41 kB Date: 03/18/2013 Disease Area: Read more about Comments to FDA on Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products
Comments to FDA on Proposed Reclassification of Flu Tests Open application/pdf - 141.25 kB Date: 08/20/2014 Disease Area: Read more about Comments to FDA on Proposed Reclassification of Flu Tests
Stakeholder Statements on the Regulation of Laboratory Developed Tests Open application/pdf - 94.77 kB Date: 09/19/2014 Disease Area: Read more about Stakeholder Statements on the Regulation of Laboratory Developed Tests
Comments to FDA on Staff-Flow Cytometric Devices Open application/pdf - 511.25 kB Date: 01/05/2015 Disease Area: Read more about Comments to FDA on Staff-Flow Cytometric Devices