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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePartoSure Test
Generic Nameplacental alpha microglobulin-1 immunoassay
Applicant
QIAGEN Inc
19300 germantown road
germantown, MD 20874
PMA NumberP160052
Supplement NumberS001
Date Received05/11/2018
Decision Date10/11/2019
Product Code QBB 
Advisory Committee Toxicology
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the revised protocol for the post-approval study (PAS) protocol
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