|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 Name||MATRITECH NMP22(TM) TEST KIT|
|Applicant||ALERE SCARBOROUGH, INC|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the change in specimen collection to a single void of urine, collected between midnight and noon, which will be tested using the matritech nmp22(r) test kit.