Microbiology Devices: Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis Complex

Document ID: FDA-2012-N-0159-0001
Document Type: Proposed Rule
Agency: Food And Drug Administration
Topics: Biologics, Laboratories, Medical Devices
Federal Register Number: 2012-06518
CFR Citation: 21 CFR Part 866
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Details Information

Abstract: References 1, 2 and 3 are FDA Transcripts
Document Subtype: Notice of Proposed Rulemaking (NPRM)
Received Date: March 19 2012, at 12:00 AM Eastern Daylight Time
Start-End Page: 16126 - 16129
Page Count: 4
Comment Start Date: March 19 2012, at 12:00 AM Eastern Standard Time
Comment Due Date: June 18 2012, at 11:59 PM Eastern Standard Time

Attachments:

Reference 4 Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis complex

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Reference 4.1 Premarket Notifications: The First 24,000

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Reference 4.2 Bureau ofEconomic Analysis. National Income and Product Accounts Table 1.1.9 Implicit Price Deflators for Gross Domestic Product National Income and Product Accounts Table 1.1.4. Price Indexes for Gross Domestic Product

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Reference 4.3 FY 2003 and 2004 Unit Costs for the Process of Medical Device Review

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Reference 4.4 Profile of Baseline Materials Management Practices of Finished Drug Product Manufacturers: Draft Final Report

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Reference 4.5 May 2010 National Occupational Employment and Wage Estimates

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Reference 4.6 Table of Small Business Size Standards Matched to North American Industry Classification System Codes

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Comments

   
Total: 3
Center for Disease Control (CDC) - Comment
Posted: 06/08/2012     ID: FDA-2012-N-0159-0002

Jun 18,2012 11:59 PM ET
Roche Diagnostics - Comment
Posted: 07/03/2012     ID: FDA-2012-N-0159-0003

Jun 18,2012 11:59 PM ET
Association of Public Health Laboratories - Comment
Posted: 07/03/2012     ID: FDA-2012-N-0159-0004

Jun 18,2012 11:59 PM ET

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