← FDA Medical Device Classifications

Ecarin Clotting Time

PBA · f · Unknown

Classification

FDA Product Code
PBA
Device class
f
Regulation
Review panel
HE
Medical specialty
Unknown
Submission type
6
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Definition

The TAS ECT Test Card is to be used with the TAS Analyzer and is intended to determine the anticoagulant effect of hirudin during CBP in patients who have HIT. It is suited for professional use in decentralized areas of testing near the site of patient care as well as for use in the more traditional laboratory. Monitoring with the TAS ECT is indicated for persons who have been identified with and/or confirmed as a high risk for HIT, and require high dose anticoagulant with hirudin for a scheduled or emergency CPB procedure.

Market data

Cleared 510(k) submissions
0
Registered establishments
0

Source

Authoritative
FDA Device Classification database
Machine
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