Draft Guidance for Industry and FDA Staff: Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked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
Document Type: Notice
Agency: Food And Drug Administration
Topics: No Topics associated with this document
Federal Register Number: 2011-13390
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Details Information

Document Subtype: NAD-Notice of Availability of Data
Received Date: May 31 2011, at 12:00 AM Eastern Daylight Time
Start-End Page: 31615 - 31616
Page Count: 2
Comment Start Date: June 1 2011, at 12:00 AM Eastern Standard Time
Comment Due Date: August 30 2011, at 11:59 PM Eastern Standard Time

Comments

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Total: 48
American Association for Clinical Chemistry (AACC) - Comment
Posted: 08/26/2011     ID: FDA-2011-D-0305-0006

Aug 30,2011 11:59 PM ET
Celera Corporation and Focus Diagnostics, Inc. - Comment
Posted: 08/26/2011     ID: FDA-2011-D-0305-0007

Aug 30,2011 11:59 PM ET
Wadsworth Center, New York State Dept Health - Comment
Posted: 09/08/2011     ID: FDA-2011-D-0305-0008

Aug 30,2011 11:59 PM ET
Neng Yu - Comment
Posted: 09/08/2011     ID: FDA-2011-D-0305-0010

Aug 30,2011 11:59 PM ET
Lucie Richard - Comment
Posted: 09/08/2011     ID: FDA-2011-D-0305-0011

Aug 30,2011 11:59 PM ET

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