Microbiology Devices: Classification of In Vitro Diagnostic Device for Yersinia Species Detection

Document ID: FDA-2011-N-0729-0001
Document Type: Proposed Rule
Agency: Food And Drug Administration
Topics: Biologics, Laboratories, Medical Devices
Federal Register Number: 2011-28724
CFR Citation: 21 CFR Part 866
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Details Information

Document Subtype: Notice of Proposed Rulemaking (NPRM)
Received Date: November 07 2011, at 12:00 AM Eastern Standard Time
Start-End Page: 69034 - 69039
Page Count: 6
Comment Start Date: November 7 2011, at 12:00 AM Eastern Standard Time
Comment Due Date: February 6 2012, at 11:59 PM Eastern Standard Time

Attachments:

Reference 2 - Diagnosis of Plague: an Analysis of the Yersin-Kitasato Controversy

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Reference 3 - Rapid Identification of Pasteurella pestis Using Specific Bacteriophage Lyophilized on Strips of Filter Paper; a Preliminary Report

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Reference 4 - An Evaluation of Pasteurella pestis Fraction-1-Specific Antibody for the Confirmation of Plague Infections

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Reference 5 - Comparison of the Reliability and Sensitivity of Three Serological Procedures in Detecting Antibody to Yersinia pestis (Pasteurella pestis)

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Reference 6 - Yersinia pestis--Etiologic Agent of Plague

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Reference 7 - Stable Reagent for the Detection of Antibody to the Specific Fraction 1 Antigen to Yersinia pestis

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