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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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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 HDE to get an up-to-date view of this device.
Classification Nametest, ecarin clotting time (ect)
Generic Nametest, ecarin clotting time (ect)
9401 globe center dr.
suite 140
morrisville, NC 27560
HDE NumberH990012
Supplement NumberS001
Date Received02/05/2004
Decision Date08/31/2004
Product Code
Advisory Committee Hematology
Supplement Typenormal 75 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Replacement of the knoll pharmaceuticals peg hirudin with refludan r-hirudin;an increase in lot release acceptance criteria, from precision of 8% to 10%cv, for clotting times of the ect test cards;removal of the in-process range of 180-190 seconds for target clotting times;replacement of the card calibration test procedure.