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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 NamePATH VYSION 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 NumberS013
Date Received06/16/2014
Decision Date07/16/2014
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 
Modify the validated test method mdp00644 ¿fragmented dna agarose gel electrophoresis¿ of the manufacturing process of vysis alk break apart fish probe kit, pathvysion her-2 dna probe kit and urovysion bladder cancer kit.
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