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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 NameHER2 FISH PHARMDX KIT
Classification Namesystem, test, her-2/neu, nucleic acid or serum
Generic Nameerbb2 gene amplification kit
ApplicantDAKO DENMARK A/S
PMA NumberP040005
Supplement NumberS002
Date Received10/31/2007
Decision Date02/13/2008
Product Code
MVD[ Registered Establishments with MVD ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification of the cen 17 reference pna probes in vial 3 probe mix, adjustment of the her2 gene targeted dna probe concentrations in vial 3 probe mix, change in auxiliary materials in texas red nick translation and use of sephadex g-50 columns for purification of nick translation products.
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