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Food and Drug Administration

Immunology Devices Panel Meeting

November 16, 2006

Briefing Information


The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Veridex GeneSearch Lymph Node (BLN) Assay

Proposed Summary of Safety and Effectiveness (pdf)

Proposed Labeling (pdf)

Summary of Non-clinical Studes (pdf)



Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. §552). These redacted portions will appear as white space on the screen or on the printed page.

FDA Executive Summary (pdf)

Page last updated November 8, 2006 kkhorizonal rule
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