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Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis Complex in Respiratory Specimens

Document ID: FDA-2013-N-0544-0001
Document Type: Proposed Rule
Agency: Food And Drug Administration
Topics: Biologics, Laboratories, Medical Devices
Federal Register Number: 2013-14552
CFR Citation: 21 CFR Part 866
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Details Information

Document Subtype: Notice of Proposed Rulemaking (NPRM)
Received Date: June 19 2013, at 12:00 AM Eastern Daylight Time
Start-End Page: 36698 - 36702
Page Count: 5
Comment Start Date: June 19 2013, at 12:00 AM Eastern Standard Time
Comment Due Date: August 19 2013, at 11:59 PM Eastern Standard Time

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