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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 Nameenzyme immunoassay, fetal fibronectin
ApplicantHOLOGIC, INC.
PMA NumberP920048
Supplement NumberS009
Date Received04/09/2015
Decision Date06/24/2015
Product Code
LKV[ Registered Establishments with LKV ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of a new resin in the plasma fibronectin (pfn) affinity column used to purify the a120 fetal fibronectin specific antibody contained in the rapid ffn test for the tliiq system. Additionally, the implementation of a modified arginine containing neutralization buffer to decrease precipitation of the a120 antibody from the buffer.