Device
The Coag-Sense® Prothrombin Time (PT) / INR Monitoring System for Patient Self-Testing is
Manufacturer
COAGUSENSE INC.
COAGUSENSE INC.
Model: 300550
Catalog: 300550
DI: 00860007370809
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-12
Current Version: 2026-05-20
Description
The Coag-Sense® Prothrombin Time (PT) / INR Monitoring System for Patient Self-Testing is
an 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 is
intended for use by properly selected and suitably trained patients or their caregivers on the
order of the treating physician to monitor patients who are on anticoagulation therapy. Patients
should 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 not
intended to be used for screening purposes.
The Coag-Sense® Prothrombin Time (PT) / INR Monitoring System for Self-Testing is intended
to be used by a single person and should not be shared.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
04baae4d-6ed9-4567-886d-da9cc1a0c186
Distribution Status:
In Commercial Distribution
DUNS Number:
007943352
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00860007370809
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 62541
Name: Coagulation analyser IVD, home-use, battery-powered
Definition:
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.
FDA Product Codes
None