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Immunology and Microbiology Devices; Classification of Norovirus Serological Reagents

Document ID: FDA-2012-N-0165-0001
Document Type: Rule
Agency: Food And Drug Administration
Topics: Biologics, Laboratories, Medical Devices
Federal Register Number: 2012-05675
CFR Citation: 21 CFR Part 866
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Details Information

Document Subtype: Final Rule
Received Date: March 09 2012, at 12:00 AM Eastern Standard Time
Start-End Page: 14272 - 14274
Page Count: 3

Attachments:

Petition from R-Biopharm AG, c/o Lehnus and Assocites, dated February 15, 2011

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Petition Attachment 1 - NSE Letter

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Petition Attachment 3 - Lehnus & Associates Consulting

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Pettition Attachment 2 - RIDASCREEN Norovirus 3rd Generation

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