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November 16, 2006
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)