Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing
Primary DI
00860007370809
Brand
Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing
Company
COAGUSENSE INC.
Model
300550
Catalog number
300550
Device description
The Coag-Sense® Prothrombin Time (PT) / INR Monitoring System for Patient Self-Testing isan in vitro diagnostic device that provides quantitative prothrombin time (PT) results,expressed in INR units. It uses fresh capillary whole blood.The Coag-Sense® Prothrombin Time (PT) / INR Monitoring System for Patient Self-Testing isintended for use by properly selected and suitably trained patients or their caregivers on theorder of the treating physician to monitor patients who are on anticoagulation therapy. Patientsshould be stabilized on warfarin-type (coumarin) anticoagulation therapy prior to self-testing.The Coag-Sense Prothrombin Time (PT)/INR Monitoring System for Patient Self-Testing is notintended to be used for screening purposes.The Coag-Sense® Prothrombin Time (PT) / INR Monitoring System for Self-Testing is intendedto be used by a single person and should not be shared.
An exclusively battery-powered instrument intended to be used for the qualitative and/or quantitative in vitro determination of one or multiple coagulation components involved in haemostasis in a clinical specimen [e.g., performs tests such as whole blood prothrombin time (WBPT), whole blood partial thromboplastin time (WBPTT), heparin dose response, activated clotting time (ACT)]; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. It may incorporate spectrophotometry, turbidimetry, nephelometry, electrometry and/or mechanical means of clot formation or end point detection.
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