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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.
Classification Namesystem, test, her-2/neu, nucleic acid or serum
Generic Nameerbb2 gene amplification kit
PMA NumberP040005
Supplement NumberS003
Date Received07/10/2008
Decision Date10/10/2008
Product Code
MVD[ Registered Establishments with MVD ]
Advisory Committee Pathology
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following changes: 1. Labeling change in the step 1 (pre-treatment) in the instructions for use to include an alternative method to heat the pre-treatment buffer using a microwave oven with boil sensor capability as "water bath" independently of the buffer start volume and temperature 2. Labeling change in the step 2 (pepsin, ready-to-use) in the instructions for use to include an alternative method of incubation with pepsin using a heating block, e. G. A hybridizer, and incubation at 37°c as an alternative to incubation at room temperature 3. Changes in reagent volume and vial size for vial 1 and vial 2 4. Modification of signal counting guide to include under-digested nuclei 5. Labeling change in the instructions for use to include the dako hybridizer as an alternative to the use of heating block and hybridization oven for denaturation and hybridization steps, respectively.