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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameTAS ECT TEST
Classification Nameecarin clotting time
Generic Nameecarin clotting time
Regulation Number864.5400
Applicant
CARDIOVASCULAR DIAGNOSTICS, INC.
9401 globe center dr.
suite 140
morrisville, NC 27560
HDE NumberH990012
Date Received11/08/1999
Decision Date05/11/2000
Product Code
PBA
Docket Number 00M-1354
Advisory Committee Hematology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Tas ecarin clotting time test id indicated to be used to determine the anticoagulant effect of recombinant hirudin (r-hirudin) during cardiopulmonary bypass in patients who have heparin induced thrombocytopenia (hit).
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Supplements: S001 
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