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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePATHVYSION HER-2 DNA PROBE KIT
Classification Namesystem, test, her-2/neu, nucleic acid or serum
Generic Nameneu gene assay kit
ApplicantABBOTT MOLECULAR, INC.
PMA NumberP980024
Supplement NumberS009
Date Received11/27/2012
Decision Date12/26/2012
Product Code
MVD[ Registered Establishments with MVD ]
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Qualify the geneprep instrument, qualify the overhead mixing system and validate the mixing process in the manufacture of the hybridization buffer, and transfer an existing in-process testing of labeled dna.
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