Draft Guidance for Industry and FDA Staff: Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions; Availability
Document ID: FDA-2011-D-0305-0001
Comments
Total: 48
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PerkinElmer Inc. - Comment
Posted : 06/30/2011 ID ：FDA-2011-D-0305-0003 Agency : FDA -
Aug 30,2011 11:59 PM ET
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Innogenetics, Inc. - Comment
Posted : 07/20/2011 ID ：FDA-2011-D-0305-0005 Agency : FDA -
Aug 30,2011 11:59 PM ET
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American Association for Clinical Chemistry (AACC) - Comment
Posted : 08/26/2011 ID ：FDA-2011-D-0305-0006 Agency : FDA -
Aug 30,2011 11:59 PM ET
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Celera Corporation and Focus Diagnostics, Inc. - Comment
Posted : 08/26/2011 ID ：FDA-2011-D-0305-0007 Agency : FDA -
Aug 30,2011 11:59 PM ET
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Wadsworth Center, New York State Dept Health - Comment
Posted : 09/08/2011 ID ：FDA-2011-D-0305-0008 Agency : FDA -
Aug 30,2011 11:59 PM ET
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American Society for Histocompatibility and Immunogenetics (ASHI) - Comment
Posted : 09/08/2011 ID ：FDA-2011-D-0305-0009 Agency : FDA -
Aug 30,2011 11:59 PM ET
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Neng Yu - Comment
Posted : 09/08/2011 ID ：FDA-2011-D-0305-0010 Agency : FDA -
Aug 30,2011 11:59 PM ET
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Lucie Richard - Comment
Posted : 09/08/2011 ID ：FDA-2011-D-0305-0011 Agency : FDA -
Aug 30,2011 11:59 PM ET
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Jerry C Rosenberg - Comment
Posted : 09/08/2011 ID ：FDA-2011-D-0305-0012 Agency : FDA -
Aug 30,2011 11:59 PM ET
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Donna P Lucas - Comment
Posted : 09/08/2011 ID ：FDA-2011-D-0305-0013 Agency : FDA -
Aug 30,2011 11:59 PM ET
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American Association for Clinical Chemistry (AACC) - Comment
Posted : 09/08/2011 ID ：FDA-2011-D-0305-0014 Agency : FDA -
Aug 30,2011 11:59 PM ET
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University of Rochester Medical Center - Comment
Posted : 09/08/2011 ID ：FDA-2011-D-0305-0015 Agency : FDA -
Aug 30,2011 11:59 PM ET
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Sandra Rosen-Bronson - Comment
Posted : 09/08/2011 ID ：FDA-2011-D-0305-0016 Agency : FDA -
Aug 30,2011 11:59 PM ET
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R. Jackson - Comment
Posted : 09/08/2011 ID ：FDA-2011-D-0305-0017 Agency : FDA -
Aug 30,2011 11:59 PM ET
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Association of Public Health Laboratories (APHL)- Comment
Posted : 09/08/2011 ID ：FDA-2011-D-0305-0018 Agency : FDA -
Aug 30,2011 11:59 PM ET
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Yenhui Chang - Comment
Posted : 09/08/2011 ID ：FDA-2011-D-0305-0019 Agency : FDA -
Aug 30,2011 11:59 PM ET
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Arthur Bradley Eisenbrey - Comment
Posted : 09/08/2011 ID ：FDA-2011-D-0305-0020 Agency : FDA -
Aug 30,2011 11:59 PM ET
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Corporation and Focus Diagnostics, Inc. - Comment
Posted : 09/08/2011 ID ：FDA-2011-D-0305-0021 Agency : FDA -
Aug 30,2011 11:59 PM ET
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Andrew Charles Lane - Comment
Posted : 09/08/2011 ID ：FDA-2011-D-0305-0022 Agency : FDA -
Aug 30,2011 11:59 PM ET
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Association for Molecular Pathology (AMP) - Comment
Posted : 09/08/2011 ID ：FDA-2011-D-0305-0023 Agency : FDA -
Aug 30,2011 11:59 PM ET
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Coalition for 21st Century Medicine - Comment
Posted : 09/08/2011 ID ：FDA-2011-D-0305-0024 Agency : FDA -
Aug 30,2011 11:59 PM ET
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American Clinical Laboratory Association (ACLA) - Comment
Posted : 09/08/2011 ID ：FDA-2011-D-0305-0025 Agency : FDA -
Aug 30,2011 11:59 PM ET
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American Society of Hematology - Comment
Posted : 09/08/2011 ID ：FDA-2011-D-0305-0027 Agency : FDA -
Aug 30,2011 11:59 PM ET
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Johns Hopkins University - Comment
Posted : 09/08/2011 ID ：FDA-2011-D-0305-0028 Agency : FDA -
Aug 30,2011 11:59 PM ET
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AdvaMed - Comment
Posted : 09/08/2011 ID ：FDA-2011-D-0305-0029 Agency : FDA -
Aug 30,2011 11:59 PM ET
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Luminex Corporation - Comment
Posted : 09/08/2011 ID ：FDA-2011-D-0305-0030 Agency : FDA -
Aug 30,2011 11:59 PM ET
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Robert Jay Reinhard - Comment
Posted : 09/08/2011 ID ：FDA-2011-D-0305-0031 Agency : FDA -
Aug 30,2011 11:59 PM ET
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Roche Diagnostics - Comment
Posted : 09/08/2011 ID ：FDA-2011-D-0305-0032 Agency : FDA -
Aug 30,2011 11:59 PM ET
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Scott & White Healthcare - Comment
Posted : 09/08/2011 ID ：FDA-2011-D-0305-0033 Agency : FDA -
Aug 30,2011 11:59 PM ET
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Jerry Lynn Morrisey - Comment
Posted : 09/08/2011 ID ：FDA-2011-D-0305-0034 Agency : FDA -
Aug 30,2011 11:59 PM ET